London School of Hygiene and Tropical Medicine.

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London School of Hygiene and Tropical Medicine.

MSc Project Report:

Surgical management of upper limb nerve palsies in leprosy

affected patients; literature review and project proposal.

Candidate Number: 491839

Supervisor: Professor Diana Lockwood

Submitted in part fulfillment of the requirements for the

degree of MSc in:

Tropical Medicine and International Health.

Academic year: 2009-2010

Date of submission: 23rd

Aug 2010

Word count: 9062

Project length: Standard

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Contents

1. …………………………………………………………………………………….Cover page.

2. ………………………………………………………………………………...Contents page.

3. ………………………………………………………………………………...Contents page.

4. ………………………………………………………………………………………..Abstract.

5. ……………………………...Introduction; Epidemiology and Disease Control Initiatives.

6. ……………………………………………..Pathophysiology and transmission of leprosy.

7. ……………………………………..Clinical manifestations and complications of leprosy.

8. ......................................................................................................Women and leprosy.

Diagnostics and Classification.

Ridley-Jopling Scheme.

WHO classification.

9. ……………………………………………………………………………Leprosy Treatment.

Drug Treatment for Leprosy.

Leprosy Prevention.

Disability.

10. ……………………………………………………….Measurement of disability in leprosy.

The leprosy affected hand impairment of normal function.

11. ………………………………………………………………………………………………..…

12. ……………………………………………………………………………….Leprosy surgery.

13. …………………………………………………………………………………………………..

14. ………………………………………………….Experience of leprosy surgery in the field.

Why do this review?

Aims and Objectives.

15. ………………………………………………………………………………………..Methods.

Types of studies.

Participants.

Interventions.

Outcomes measures.

Search methods.

Electronic searches.

16. ………………………………………………………………………………………….……….

17. ………………………………………………………………………………….Ongoing trials.

Unpublished data.

Language restrictions.

18. …………………………………………………………………Data collection and analysis.

Results.

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Study descriptions (appendix 1).

Search results.

Included studies.

Excluded studies.

19. ………………………………………………………………………..….Intervention effects.

Which surgical options for stable upper limb paralysis have good outcomes?

In claw hand.

20. …………………………………………………………………………………………………..

21. ………………………………………………...……….…..For postoperative interventions.

22. ……………………………………………………………………………..For simian thumb.

23. …………………………………………………………………………………………………..

24. ……………………………………………………………………………..Quality of Studies.

25. …………………………………………………………………………………………………..

26. ………………………………………………………………………..Study Heterogeneity.

27. …….Most effective surgical intervention for the management of upper limb paralysis?

Interventions most effective at improving quality of life or stigma?

Adverse events/unwanted side effects of surgery?

28. …Is immediate physiotherapy better than immobilization in leprosy related paralysis?

29. ………………………………………………....……….Discussion and recommendations.

30. …………….. ………………………………………………………………. Future research.

31. ……………………………………..Appendix 1; detailed description of studies included.

32. …………………………………………………………………………………………………..

33. …………………………………………………………………………………………………..

34. …………………………………………………………………………………………………..

35. ……………………………………………………………...Appendix 2; research proposal.

36. …………………………………………………………………………..Acknowledgements.

37. …………………………………………………………………………………….References.

38. .……………………………………………………………………………………References.

39. …………………………………………………………………………………….References.

40-52.................................................................................................................CARE form.

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Abstract

Background

Nerve damage affects 30% of leprosy patients. At present about 6-9% of individuals

newly presenting with leprosy have grade 2 disabilities and 3 million people worldwide are

disabled due to the affects of leprosy.

Objectives

To assess outcomes of surgery and post operative techniques to improve upper limb

nerve paralysis second to leprosy.

Search strategy

Data bases searched; Cochrane Central Register of Controlled Trials, Medline,

Embase, Global Health/Global Health Archives, Africa Wide NiPAD, CINAHL, LEYES (Latin

America and Caribbean) LILACS (South America) and online registers of ongoing trials.

Study selection

Leprosy affected patients with upper limb nerve paralysis that have been entered in

to studies looking at surgical or post operative intervention outcomes.

Data collection and analysis

Data was electronically or by hand retrieved and assessed for quality and content.

Main results

Eleven trials were included with a total of 1161 operations and 998 participants. All

trials were small, diverse and the quality was generally poor. Studies included had between

23 to 246 operations (20 and 216 participants) for leprosy related disabilities. Six studies

looked at correction of the claw hand, one randomized control trial looked at postoperative

intervention. Four studies looked at opponensplasty to correct the simian thumb. Studies

were from 1958 to 2008 spanning 60 years of surgical research.

Conclusions

Though there was some consensus among studies as to pre-operative function

predicting post operative function and the importance of physiotherapy the wide variability in

the type, design and techniques used prevented consensus being drawn on the best

surgical options for correction of the upper limb nerve palsy.

There is a severe lack of good quality research on the best practice for surgical

correction of upper limb nerve palsies in leprosy affected patients. New trials need to follow

modern standards for designing and reporting controlled trials.

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Introduction

Epidemiology and Disease Control Initiatives.

Despite decades of intensive effort to control leprosy the disease remains an

important global issue. In 1985 it was estimated that there was approximately 12 million

people worldwide affected by leprosy. In 2006 the prevalence was registered as 224,717[1].

The remaining numbers are concentrated in a handful of countries clustered in limited

geographical sites and ethnic groups[2].

Early diagnosis efforts and the availability of free multi-drug therapy (MDT) through

the WHO have lead to a decrease in prevalence in most endemic countries. Some 11

million[1] people have been treated with MDT.

The 2009 WHO statistics show a continued decrease in prevalence. The lengthy

disease progression and because it occurs in the poorest most marginalized communities

makes epidemiological study difficult. Yearly incidence of new cases has not matched the

decline in prevalence; this may be due to better surveillance and detection or indicate

ongoing transmission.

In 1986 the elimination of leprosy by 2000 was first proposed. This was later modified

to “elimination as a public health problem” (less than 1 case per 10,000 population) and

adopted by the World Health Assembly in 1991[3]. This target has proved unattainable to

date. Leprosy cure with MDT however does not presuppose absence of disability.

Reactions, progressive silent neuronal damage and increasing disability can persist after

MDT completion.

The “Final Push” strategy launched by the WHO in 1999 ran from 2000 till 2005 and

was launched in recognition that elimination by 2000 could not be achieved. Focus shifted

toward intensified initiatives in countries where endemicity remains problematic[4]. “Global

strategy for further reducing leprosy burden and sustaining leprosy control activities”,

promoting an integrated approach, ran from 2006 to 2010. MDT remained the management

cornerstone but with added emphasis on community involvement[5]. There has been a

recent move to appreciate the chronicity of leprosy disability with stigma and social exclusion

adding further to patient burden. The proposed “New Enhanced Global Strategy for further

reducing the disease burden due to leprosy” will run from 2011 to 2015. This introduces the

global target of reducing new cases with grade 2 disabilities per 10,000 population by at

least 35% by 2015 compared to the 2010 baseline[6].

Areas where leprosy remains a problem and the WHO‟s target is still elusive include

India, Nepal, Angola, Brazil, Central African Republic, Democratic Republic of Congo,

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Mozambique, Tanzania and Madagascar[1] India alone accounts for 64% of all Leprosy

cases worldwide[2].

Pathophysiology and Transmission

Leprosy is a disease caused by the intercellular Mycobacterium Leprae. The

mycobacterium has a predilection for macrophages and nerve Schwann cells and causes a

chronic granulomatous infection of nerves and skin[7]. Infectivity appears to be low and

many who become infected never manifest disease[8]. Proximity appears to be the most

important factor affecting risk of acquiring leprosy; a household contact runs 2-4 times the

risk of contracting leprosy cohabiting with someone who has tuberculoid disease and 8-10

times contacting lepromatous disease[9]. It is held that infection is due to nasal

secretions/respiratory transmission. Man is the only known reservoir although

Mycobacterium Leprae has been shown to be present in the nine-banded armadillo.

M. Leprae is difficult to study due to slow evolution of the disease, lack of animal

models and our inability to culture the organism. Clinical presentation is largely dictated by

the host‟s immune response. This separates those with Tuberculoid Leprosy: a strong

immune response to a small mycobacterial burden, from Lepromatous leprosy: patients with

minimal inflammatory response to a heavy mycobacterial load. Between these extremes are

three borderline levels; borderline tuberculoid, borderline and borderline lepromatous.

Intervals between infection and disease presentation are variable; on average10 years for

lepromatous leprosy and about four for tuberculoid[8].

The two extremes of disease are generally stable. Those suffering from borderline

disease are prone to reactions. Reactions can be Type 1 reversal reactions, which can affect

all types of borderline leprosy and post partum women, and is due to delayed

hypersensitivity to M. Leprae antigen in the nerves and skin[10]. Type 2 reactions,

(Erythema Nodosum Leprosum) affect those with lepromatous or borderline lepromatous

leprosy. These are due to T cell dysfunction with excess TNF production and immune

complex deposition within skin nerves and organs[10]. Neuritis can occur without reactions

and can be acute, chronic or silent with no symptoms until appearance of functional deficit.

Nerve involvement can leave patients with combinations of anesthesia and paralysis leading

to progressive disability and stigmatizing disfigurement.

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Clinical manifestations and complications

Leprosy is a complex disease with a host of slow and fast evolving presentations. The

cardinal symptoms/signs of leprosy are;

Hypo pigmented anesthetic skin lesions (figure 1).

Thickened peripheral nerves.

Acid fast bacilli on slit skin smear[10].

Skin lesions are often the first presentation. These are usually

ill-defined hypo-pigmented areas with none or mild sensory

impairment. Sweating and hair growth are unaffected[8],

other symptoms include areas of numbness or muscle

weakness. Occasionally patients can present with reactions

and systemic symptoms including fever and

lymphadenopathy.

In established disease the spectrum of presentation

reflects the complex interaction between mycobacterium and immune response. In

lepromatous disease skin lesions have ill-defined edges are macular bilaterally symmetrical

and numerous. Nerve damage is slow to appear and usually presents asymmetrically distally

in the limbs. The sensory modality is commonly affected first with later development of

weakness. There can be dense skin infiltration, damage to the eyes, face (Leonine facies)

and nasal collapse with organ damage of insidious onset[8].Infiltration of the testis can

cause infertility, decreased testosterone and resultant osteoporosis, impotence and

gynaecomastia[8].

Tuberculoid leprosy occupies the other end of the spectrum, often with only one or a few

skin lesions with discrete borders, red/orange in color. Nerve damage is early and the

bacillary index is low[11]. Lesions can self heal leaving no impairment, however with larger

inflamed lesions there is greater risk of nerve involvement. Specific major peripheral nerve

trunks not directly involved with skin lesions can become inflamed including,

Ulnar nerve at the olecranon groove.

Posterior tibial nerve as it traverses behind the medial malleolus.

Common peroneal nerve in the popliteal fossa.

Radial cutaneous nerve at the wrist.

Facial and greater auricular nerve (often visible in the neck).

Median nerve before entering the carpel tunnel[8].

In the large multicentre INFIR study the posterior tibial and sural nerves were most

commonly affected though other studies have produced different results[12-13].

Figure 1. Hypo-pigmented skin lesions.

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Sensory nerve function is usually first affected however sensory motor and autonomic can

occur synchronously. Despite the range of complications that occur in leprosy it is thought

that many infections are subclinical, of those who do progress to clinical disease only 2%

progress to long term disability[14].

Women and Leprosy

Women are a minority when it comes to infection with leprosy.

Disability appears to occur just as commonly however. Studies tend to

find that women are less like to present for treatment leading to a

greater proportion of women being disabled long term[15]. This may be

due to increased difficulties for women in accessing health care for a

variety of reasons, including greater poverty and lower social standing.

One study looking at women with leprosy and the role of surgery found

admission and inpatient care for surgical correction of disability was

more distressing and a greater social upheaval for females than

men[16].

Diagnostics and Classification

Ridley-Jopling Classification

Leprosy diagnostics is a combination of clinical testing in combination with

identification of acid-fast bacilli on slit skin smears. This allows for the patient to be placed

on the Ridley Jopling[17] classification scale and guide management. Sensory nerve

dysfunction can be measured using monofilaments or simple sensory discrimination using a

ballpoint pen or cotton wool. Motor function can be assessed using voluntary muscle tests

and if available dynamometry. Nerve conduction studies are the often not available, gold

standard[18].

WHO Classification

In 1998 the WHO introduced [19] the simplified pauci and multibacillary criteria to

guide treatment. This field tool uses number of skin lesions to dictate classification with

paucibacillary being up to 5 lesions and multibacillary being 6 or more. Studies have shown

that the addition of further information such as nerve testing can add to sensitivity and

specificity of this simplified classification[19-20].

Figure 2 Nepali women affected by leprosy with severe disability.

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Treatment

Drug Treatment

MDT is highly affective (relapse of less than 1%)[21] and

defends against resistance emergence. Paucibacillary disease is

treated with 6 months of Rifampicin and Dapsone. Multibacillary is

treated with Rifampicin Clofazimine and Dapsone for a year[10].

Acute nerve involvement in leprosy has been managed

medically and surgically. Reactions and neuritis are treated with

various regimes of steroids and steroid sparing alternatives[10]. A

meta-analysis looking at surgical decompression compared to steroid

treatment alone in acute nerve impairment does not support the use

of surgical management. This however was only based upon two

non-blinded randomized controlled trials of 88 people and the authors call for further studies

to be conducted[22]. The AMFES study found that 88% of those with a single acute

neuropathy treated with steroids made a full recovery[23-24]. The multicentre TRIPOD

randomized placebo controlled trial however has not shown a sustained reduction in

incidence of new reactions and nerve function impairment in using prophylactic steroids for

longer than a year to prevent new disability in MDT treated patients[25].

Prevention of Leprosy

Leprosy prevention would be the ideal to prevent related disability. There is

continuing efforts to prevent transmission through MDT. New research in to BCG given in

infancy and Rifampicin to household contacts show a combined protective effect of about

80%[26] and if this strategy could be deployed it might be the final step to control the

disease and prevent resulting disabilities.

Disability

Disabilities second to leprosy are due to interplay between leprosy type, reactions

occurring and interim between infection and treatment. Nerve involvement can affect eyes;

upper and lower limbs but early management can prevent damage occurring[27-28].

Management of individuals once damage has occurred is more difficult and there is a role for

surgery. The AMFES study in Ethiopia found that delay in presentation and age are the main

risk factors for impairment[29] and those with chronic and recurrent neuropathy have a

worse prognosis. Impairment at diagnosis was also associated with worse long term

Figure 3 Adult MDT combination drug packs.

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disability[23] this is also supported by the BANDS study in Bangladesh[30]. The INFIR study

in India also identified that even subclinical nerve dysfunction along with increased serum

TNF were predictive of future nerve impairment[31].

To combat secondary damage occurring after nerve involvement self-care has been

promoted and has been demonstrated to be an effective means of preventing further tissue

damage, hence self-care education is being encouraged in primary care in leprosy affected

areas[32].

Measurements of Disability

Disability can be comprehensively measured by the WHO‟s International

Classification of Functioning Disability and Health (ICF) which assesses all aspects of

disability affecting quality of life[33]. This holistic but complex scoring system is appropriate

for any cause of disability but is not easily used in field settings. Specific for leprosy and

probably most widely used is the WHO disability grading for leprosy and consists of scoring

eyes hands and feet on left and right.

Alternative scoring systems for leprosy especially when looking at activity and

participation in low income countries include the SALSA score[34] and the WHODAS[35]

scoring system. There are also scoring systems that look specifically at disabilities in the

upper limb such as the DASH (Disabilities of the Arm, Shoulder and Hand) score[36].

The leprosy affected hand; impairment of normal function.

The function of the hand is based on grip and sensation. Leprosy produces severe

hand dysfunction through damage to the ulnar, median and radial nerves. Loss of ulnar and

median function paralyses the intrinsic muscles of the hand. This leads to loss of balance of

the digits, exacerbated by the uncontrolled pull of the long extrinsic muscles, flexor and

extensor.

The ulnar nerve animates most of the intrinsic

muscles of the fingers. Paralysis of the intrinsics leads to the

characteristic claw hand, or „Intrinsic minus‟ (figure 4). The

interossei and lumbricals flex the metacarpophalangeal

(MCP) joints and extend the interphalangeal (ICP) joints.

Their paralysis leads to hand clawing: hyperextension of the

MCPJ and flexion of the IPJ, made worse by the long

extensor pull of the MCP joint furthering extension. An

Figure 4. Ulnar nerve paralysis; claw hand.

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attempt to open the hand, to grasp an object is usually achieved by a synchronous extension

of the chain of digital joints. In the clawed hand there is acute hyperextension of the MCP,

while the IPJ‟s remain flexed and the patient‟s hand is unable to surround an object.

Synchronous flexion is also impaired. Normal closing of the hand allows for

maximum contact with an object and maximal grip. Functioning lumbricals ensure

simultaneous and synchronised flexion of the chain of digital joints. The clawed hand starts

from a position of severe flexion of the ICP joints and extension of the MCP joints with loss

of the controlling function of the lumbricals.

Adduction and abduction are also lost. The failure to spread the fingers wide, limits

the versatility of the hand, since the hand cannot conform to an uneven object wider than the

palm. Advantageous grip is lost and effective grip strength is further diminished.

The thumb occupies a unique role in the hand. The mechanism of loss outlined

above, also affects the thumb, with crucial loss of unique arcs of movement. Loss of

adduction in the thumb web space (adductor pollicis paralysis) weakens or abolishes key

grip[37], the grasp of an object between thumb tip and side of index finger. Opposition is a

composite movement made up of a sequential abduction, pronation and flexion, such that

the thumb comes to face the long digits centred on the middle finger. This opposition action

of the thumb is essential to the production of power grip to which the thumb contributes an

estimated 40%. Opposition also permits the grasping of a fine object between thumb, index

and middle fingers („Chuck‟ or „Three point‟ grip) and very precise manipulative function can

be achieved (e.g. holding a pen in writing).

Opposition is lost with paralysis of the median nerve, while pinch power will be

maintained if the ulnar nerve is not affected; in most cases median and ulnar palsy occur

together. For around 60 years tendon muscle unit transfer has been used to correct both

these deformities[38], often in the same procedure.

The adequate range of joints and powerful, synchronous function of muscles is

significantly handicapped by the loss of the other great modality in the hand: Sensation. Erik

Moberg, who pioneered sensory testing in the hand, wrote „The insensate hand is the blind

hand‟[39].

Unlike the pure motor deficiency of the polio

hand, the leprosy hand loses both power and

sensation. The available motor function is made

inaccurate by the loss of proprioception. Loss of

protective sensation also makes the hand vulnerable to

secondary injury, ulceration, repeated infection and

osteomyelitis. This leads to loss of length of the digits, Figure 5. Leprosy mitten hand.

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secondary scarring and contractures. Progressively, the almost useless leprosy mitten hand

(figure 5) develops, leaving the patient severely disabled[40].

Leprosy Surgery

Surgery in leprosy has many roles. The surgeon can be involved in acute and

chronic nerve management, in the management of ulcers and in reconstructive and cosmetic

surgery. Surgery in the leprosy hand aims to make maximal use of the available resources

(muscle units). Active tendons are transferred to more essential functions; contractures are

released; joints are stabilised. The function overall is improved. All such surgery is directed

at the motor aspects of the disability.

No standard procedures are available for the restoration of sensation, other than

decompression of acute intraneural nerve abscesses aimed at halting progression of nerve

damage.

Principles of surgery in leprosy affected hands include:

1. Stiffness and limitation of passive range should be corrected first.

2. Instability must be corrected by procedures such as tenodeses, joint stabilisations

and selected fusion.

3. Dynamic instability, such as the claw hand, requires dynamic solutions.

4. Tendon transfer and stabilisation surgery should only be contemplated in the treated

patient with a stable motor pattern.

The improvement of function in the leprosy-affected hand with the use of tendon muscle

unit transfer is dependent on several factors. A functioning tendon muscle unit must be

available and in the case where multiple nerve palsies exist in a single limb these options

can be limited. The power ratio and the excursion of the transferred muscle must match the

function, which is being restored[37].

Correction of the claw hand is based on the principle that if the metacarpophalangeal

joints can be stabilised at 5-10 flexion then extensor digitorum communis can actively

extend the interphalangeal joints leading to finger opening[41]. Various muscle units can be

used.

The use of extensor carpi radialis longus (ECRL) in the extensor to flexor procedure was

introduced by Littler and popularised by Brand[38]. Palmaris longus (PL) transfer was

introduced by Lennox[38]. Flexor digitorum superficialis (FDS) transfer, using the one tendon

split into four tails, is amongst the commonest performed. These tendon slips can be

inserted into a choice of sites, including the extensor mechanism, the lumbrical tendon (as

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popularised by Bunnell) or in a relatively static fashion, into the A1 pulley, the Zancolli lasso.

Other muscles, such as Extensor carpi radialis brevis have been used.

Median nerve paralysis produces atrophy of the thenar muscles. The thumb is

habitually held flat in the plane of the palm (the „simian‟

thumb) and opposition is lost. Opponensplasty is

indicated, supplemented by an adductorplasty if ulnar

nerve paralysis has also caused loss of adductor pollicis

function. Opponensplasty aims to recreate abduction-

opposition of the thumb and stabilise the proximal phalanx

restoring three-finger pinch and a grip of adequate strength.

Bunnell was the first to clarify the requirements for a successful

opponensplasty: the tendon must pull subcutaneously in the direction of the pisiform bone

and should insert on the dorso-ulnar aspect of the base of the proximal phalanx of the

thumb. He preferred to use an available flexor superficialis with a pulley constructed at the

insertion of the flexor carpi ulnaris. Since that time almost every available tendon around the

wrist has been used, and most of the procedures require the construction of a pulley or the

use of an intervening tendon graft.

Surgical correction of radial nerve palsies is much less commonly indicated and

usually in combination with median and ulnar nerve paralysis. Triple nerve palsies occur in

less than 1% of those with nerve involvement due to leprosy[42-43] and have been omitted

from this review.

The use of surgery in the management of ulcer care, correction of nerve palsies in

the lower limb, eye care and aesthetic facial surgery have been documented in the literature

but good randomised controlled trials are lacking in these areas.

The timing of surgical corrections is also important. Surgery is not attempted on an

evolving picture, whether this is deteriorating or improving. Brandsma et al suggest that

functional recovery of ulnar or median nerve paralysis is unlikely after 6 months. This is the

watershed period beyond which tendon transfers should be considered on a stable clinical

picture[44].

This review does not consider non-surgical modalities, such as early steroid therapy.

A recent meta-analysis by Reinar et al[45] looked at ways to improve ulcer healing while

avoiding surgery, but includes the observation that much of the work in this field is poor and

of limited use to analysis.

Figure 6 Simian thumb

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Leprosy surgery in the field.

During 2010 I was invited to accompany a visiting

consultant plastic surgeon specializing in

reconstructive hand surgery to Nepal. The trip to

Anandaban Hospital Kathmandu allowed me to

experience firsthand the affects that leprosy can

have on affected individuals and what surgically

can be done to alleviate their disabilities. During

my week visit I was able to assist in and lean from

an expert about the indications, choices and technical aspects of performing tendon transfer

surgery.

Why do this review?

Surgical tendon transfer has been used for 60 years to treat those with leprosy

affected by upper limb nerve paralysis. Nerve damage affects at least 30% of people

diagnosed with leprosy especially those with a high bacillary index[45] (46% in one large

study[13]). At present about 6-9% of people with newly diagnosed leprosy present with

grade 2 disabilities[3].Grade 2 includes disability from affected eyes with visual acuity < 6/60,

and visible impairments to the hands and feet including; burns, cracks, ulcers, muscle

atrophy, bone absorption and contractures[33].

Aims and Objectives

To comprehensively search the literature available on the follow up and outcomes of

patients affected by established upper limb nerve palsies caused by leprosy and having

undergone reconstructive surgery. Assessment of the various operations used and the

postoperative management employed. I will try to draw conclusions as to the best patient

management from the literature available or to at least highlight where further research is

required. Secondarily I will assess if these operations reduce disability are socially

acceptable to patients if there is an improvement in quality of life at follow up and if there is a

reduction in stigma due to improved function/appearance of patients. I will also try to

ascertain if there are any harmful side effects of the operations undertaken.

Figure 7 Tendon transfer surgery in Nepal on leprosy affected patients.

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Methods; Criteria for considering studies for review

Types of studies

Randomized controlled trials are the ideal. Most likely only retrospective, follow up and

prospective trials are going to be available.

Participants

Anyone who has suffered from upper limb nerve paralysis due to leprosy having received

MDT and has been entered in to study looking at outcomes of surgery or postoperative

interventions.

Interventions

Types of surgery performed, postoperative interventions, complications of surgery.

Outcome measures

1. Improvement in hand mechanical outcomes post-operatively.

2. Improvement in disability (ability to do appropriate functional tasks post-

operatively).

3. Quality of life measures or other functional or psychological measures.

4. Adverse events/unwanted side effects of surgery.

5. Acceptability to patients of surgery/inpatient time.

6. Aesthetic improvement in hand(s).

7. Cost to patient including travel, time off work, and educational loss for those

school age.

8. Cost effectiveness of intervention(s).

Search methods for identifying studies.

Electronic Searches

Search of the Cochrane Central registrar of Controlled trials using;

#1 Leprosy: title abstract and keyword

#2 Hansen‟s: title abstract and keyword

#3 MeSH term Leprosy explode all trees

#4 (#1 OR #2 OR #3)

#5 Surgery: search all text

#6 Disability: search all text

#7 (#5 OR #6)

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#8 (#4 AND #7)

Search results 19 (4 Cochrane reviews, 1 other review, 13 clinical trials, 1 economic

evaluation).

Search of Medline (OVID)

1) Leprosy- key word

2) Hansen* Disease- key word

3) Mycobacter* Leprae- key word

4) MeSH term Leprosy explode all trees

5) 1 OR 2 OR 3 OR 4

6) Surgical

7) Surgery

8) Operative

9) 6 OR 7 OR 8

10) Neuropath*

11) Nerve pals*

12) Nerve paralysis

13) Nerve damage*

14) 10 OR 11 OR 12 OR 13

15) 5 AND 9 AND 14

Search results 64

Search of Embase (OVID) same search used as for Medline.

Search results 143

Search of Global Health/Global Health Archives (OVID) same search as for Medline.

Search results 50

AfricaWideNiPAD

Search mode Boolean/Phrase

S1) Leprosy

S2) Hansen*

S3) (S1 OR S2)

S4) Surgery

S5) Hand*

S6) Upper limb*

S7) Arm*

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S8) (S5 OR S6 OR S7)

S9) (S3 AND S4 AND S8)

Search results 23

Search of CINAHL

Same search as used for Africa Wide NiPAD

Search results 32

LEYES (Latin America & Caribbean)

Search term Leprosy AND Surgery

Search results 0

LILACS (South America)

Search term Leprosy AND Surgery

Search results 40

References from identified published data were used to trace further studies.

Ongoing trials

A search for ongoing trials was conducted (www.controlled-trials.com/mrct/,

www.who.int/trialsearch).

One study on the subject of disability management in leprosy patients that has recently been

completed is registered;

Clinic-Epidemiological Evaluation of Ulcers in Leprosy Patients and the Use of Low Level

Laser Therapy: a Randomized Clinical Trial. Clinical trials .gov identifier NCT00860717

No studies in to surgical management of disability in leprosy or further relevant studies have

been registered at this time.

Unpublished data

ELDIS

Search term “leprosy” produced 23 documents.

Language Only those studies in English where reviewed due to time restrictions.

http://bases.bireme.br/cgi-bin/wxislind.exe/iah/online/?IsisScript=iah/iah.xis&base=LEYES&lang=i

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Data collection and analysis

Study selection was based on any study that looked at surgical management or post

operative care of upper limb nerve palsies and either compared different techniques with

follow up, or looked at pre and post operative comparison for single surgical technique.

Included where follow up studies, prospective and retrospective studies.

Results

Detailed study descriptions. See Annex 1.

Search Results.

In total the search of the listed databases found 371 possibly relevant papers. 40

Papers were retrieved either electronically or by hand from libraries including London School

of Hygiene and Topical Medicine, The Royal College of Surgeons the British Medical

Association library and The British Library.

Included studies

11 trials were included, a total of 1161 operations conducted/reviewed and 998

participants. All trials were small and included between 20 and 216 participants (23 to 246

operations) for leprosy related disabilities. Six studies looked at correction of the claw hand,

one randomized control trial looked at postoperative intervention. Four studies looked at

opponensplasty to correct the simian thumb. Studies were from 1958 to 2008.

All of the studies had high risks of bias, due to non-random patient allocation lack of

blinding and poor documentation of losses to follow up. Only one study (the most recent) by

Rath et al made an attempt at randomization via sealed envelopes and at blinding of

assessors but was too small to draw definite answers from.

Excluded studies

Papers with very small numbers such as case studies were excluded. Papers without

English texts were excluded due to time constraints. Studies looking at the use of static

procedures (e.g. capsulorrhaphy[46]) were excluded. Papers that included studies on

sensory re-enablement were excluded, as this is not current practice. Research on surgery

in the lower limbs or face was excluded.

19

Intervention Effects.

Which surgical options for stable upper limb paralysis lead to good out comes?

Claw hand correction (ulnar paralysis)

Comparisons between operations for ulnar paralysis were difficult due to the various

ways in which outcomes where measured and also due to the wide variety of different

surgical techniques employed.

Correction of claw hand using Flexor Digitorum 4 Tailed procedure (FDS-4T) or

Zancolli’s Lasso procedure (ZLP) [37].

Ozkan et al‟s study in 2003 compared out comes in patients with ulnar nerve palsy

having undergone corrective surgery either with FDS-4T or ZLP procedure both use FDS but

attachment to the MCP joint varies. Conclusions drawn by the authors were that there was

no significant difference in grip strength in the two groups post operatively. Comparison with

pre-operative assessment showed a 20% increase in grip power of patients having

undergone ZLP and 1% in FDS-4T (P<0.05). The authors propose that this may show

evidence of a superior grip improvement with ZLP procedure. The authors also compare

hands that have undergone FDS-4T procedure with lesser or greater extensor lag

suggesting longer standing/more severe clawing of the hand. The conclusion drawn is that

those with lesser extent of extensor lag (<30) preoperatively benefit the most from

intervention (P<0.05). Final conclusions drawn are that while the FDS-4T procedure was

more effective at correcting claw hand deformity the ZLP procedure was more successful at

restoring grip strength [37]. This conclusion however this did not seem fully supported by the

research and appeared to be more based on the author‟s experience.

Comparison of effectiveness of different motor muscles in a lasso procedure for

correction of claw hand[41].

Malaviya in 2003 reported a retrospective study of 65 hand operations. All patients

underwent a modified lasso procedure but four different muscle tendon units were used.

Observations were that palmaris longus (PL) or extensor carpi radialis longus (ECRL)

resulted in good or excellent grades in most cases. The use of flexor digitorum superficialis

(FDS) from the index or middle finger produced poorer results. The authors also noted that

the working space of the hand (the ability of fingers to acquire postures needed for

manipulative activities) were best restored with PL or ECRL transfers the working space

being 50% less in those with FDS transfer. Problems with the use of PL are also highlighted

and the final conclusion is that the authors support the use of a lasso procedure with ECRL

20

at the tendon motor unit. The paper however doesn‟t assess presence of side affects when

using ECRL and the statement of preference is only partially supported by the findings.

Comparison of extensor to flexor operation or use of palmaris longus for correction

of claw hand[38].

Taylor et al conducted a follow up study in 2004 looking at differences in outcomes of

various operations to correct 65 claw hands. PL tendon transfer was conducted on 40

hands and extensor to flexor operation with ECRL was used on 25 hands. Each hand was

assessed prior to surgery and then post-operatively. The conclusions drawn were that there

was no statistically significant difference in the clinical outcomes of the two different

procedures neither in angle measurements (P>.05), technical grade (P=0.5) nor in patient

satisfaction (P>.05). However due to the supposed greater ease of patient re-education and

the lack of appreciable loss of function when removed from its original position the authors

recommend that where PL is available it should be first choice. This appears to contradict

Malaviya‟s study in 2003, it does seem to be more through with more statistical evidence

however again the study is small and how much solid evidence can be drawn form an

underpowered trial is questionable.

Claw Finger Correction: Result of Extensor-Flexor Many Tailed Operation[47].

Brandsma et al followed up 155 operations, 45% of the total operation list from an

Ethiopian hospital between 1967 and 1976. The authors initially highlight that there is some

improvement in function during pre-operative physiotherapy. They also demonstrate that in

their series younger patients tended to do better post-operatively excellent/good achieved in

58.5 % compared to 49% in the over 50‟s. They however feel that this is due to shorter

length of paralysis in the younger group rather than patient age. The study shows an

association between preoperative function and surgical outcome. Hands with flexion

deformities having poorer results than patients with less pre-op deformity (0º contracture

angle excellent/good outcome 47%, greater than 40º contracture angle 29% excellent/good

outcome). The size of this study makes it more convincing however there are some serious

flaws such as recall bias. Much of the conclusion also seems based on personal opinion

which while still valid is not completely supported by the research conducted.

Paralytic claw hand (1958) and Tendon Grafting (1961)[48-49].

Brand conducted two studies one in 1958 and one in 1961. The first study followed-

up 150 operations (112 patients) having correction of claw hand by flexor digitorum

superficialis (FDS) procedure. They reported that the transfer gave good or excellent results

in 73% of fingers and commented that fingers that where stiff preoperatively produced

21

poorer results postoperatively. Analysis of fist closure postoperatively reported only 5% had

poor results and results for correct mechanism of finger closure (proximal to distal) only 2%

poor results. Overall the author cites that 75% of patients have restored hand opening and

over 90% correct hand closure. Brand then goes on to point out the complications of this

operation including the excessive force that the FDS can produce leading to new deformities

and also the weakness in the donor finger. From this he further suggests that FDS should

only be used in the stiff or contracted hand or that the tendon of a single FDS tendon should

be split to reduce excessive pull or other operations such as extensor to flexor transfer

should be considered. His second study in 1961 looked at outcomes of 246 hands having

had tendon graft using extensor carpi radialis brevis (ECRB) as the motor muscle. This

study concluded that this operation produce excellent results in 24% good/fair result in 71%

and poor results in only 2%. He reported that this was a better result than his previous study

using FDS but emphasized that this was not only due to the operative technique but to do

with case selection, which meant the operation was only performed on those with supple

non-contracted hands. Brands studies though large were conducted on two very different

patient populations and are not comparable. The conclusions drawn by the authors though

supported to some extent by their findings are not conducted against any control and so is

difficult to take the results as conclusive.

Postoperative intervention after claw deformity correction.

Only one study was identified that looked directly at postoperative interventions after

tendon transfer surgery in the leprosy hand. Many of the other studies (Taylor et al,

Brandsma et al, Brand) highlight the importance of postoperative physiotherapy in producing

good long-term results.

Randomized clinical trial comparing immediate active motion with immobilization

after tendon transfer for claw deformity[50].

Rath et al in 2009 published a study looking at immediate postoperative care. 50

claw hand deformities where randomized to two groups. For one group physiotherapy was

started days 2 postoperatively and in the other on day 22 after conventional immobilization.

Groups where compared on a number of outcomes (see appendix 1) and compared at

discharge and then at over one year. Four patients where lost to follow up. The author‟s

conclusions at the studies end were that there was no difference in outcomes except for pain

relief and restoration of hand function; these were achieved significantly earlier in the early

mobilization group. They state that morbidity was reduced by on average 22 days with early

active mobilization.

22

This study is a lot more like what is expected from current trials, with an attempt at

blinding and randomization. While the conclusions are supported by the results the main

problem with this study is that it is underpowered and further studies would need to be done

to support change in current practice.

Simian thumb correction (median median/ulnar nerve paralysis)

Four studies looked at correction of the simian thumb. It was impossible to compile

these studies due to the variety of operations conducted the varying technical operative

aspects and the different outcome measures.

Assessment of results of opponensplasty[51].

Schwarz reviewed 156 opponensplasties in 2003. The authors compared pre and

postoperative function. The majority were oppoensplasties using FDS (94%) the minority

were using flexor pollicis longus (FPL). Their findings were that there was an 89%

good/excellent result based on their scoring system (appendix1). They recorded that 94% of

patients who underwent subjective assessment reported good/fair satisfaction. The authors

highlighted that there was little correlation in patient‟s subjective opinion of outcome and

objective outcome measure. Subgroup analysis looked at whether older patients (50+) had

more difficulty in muscle reeducation but found no difference and suggest that surgery of this

kind is beneficial in older and younger patients. The observation that those undergoing

concomitant claw corrections had as good outcome as those having the opponensplasty

alone was also made. On average those having re-do operations had them at an average of

32 mouths (range 4-81 mouths) after the original operation. Complications where also

documented including early and late events (see appendix 1). The authors conclude that

subjective measurement of results by patients are important and should be included in

findings and that overall outcomes were good for the opponensplasty conducted with either

FDS or FPL.

This study was open to several types of bias and while it does include a relatively

good sized patient group most of the conclusions drawn are based on personal opinion and

experience making the applicability of the results to further studies minimal.

Results of thumb correction in leprosy using different techniques[52].

Study by Patond et al investigated outcomes of FDS or extensor indicis proprius

(EIP) for thumb reanimation. The use of FDS produced good results 87.5% of the time and

75% of the patients reported improvement in functional capabilities. EIP transfer was used in

seven hands due to high ulnar paralysis. 85.7 % had good results and 57% of patients

reported improvement in their functional capabilities. The authors recommend the use of

23

FDS as it provides greatest strength and as many leprosy affected individuals are in rural

settings in less developed countries a high proportion are farmers requiring powerful grip.

They also recommend the use of a window in the flexor retinaculum as the fulcrum as this

provides optimal direction of pull and isn‟t prone to stretching and tendon transfer laxity. The

use of EIP is only recommended where there is high ulnar nerve paralysis and the use of

FDS would lead to a functional deficit in the donor finger. Like other papers (Schwarz et al

and Brandsma et al) this study recommends that opponensplasty can be safely done

concurrently with claw hand correction however the paper produces little evidence to support

this conclusion. Like the other papers on opponensplasties there is no statistical back up to

support the recommendations and generally the size and quality of the trial does not make

for convincing conclusions to support recommendations.

Single tendon-two insertion versus two-tendon transfer for re-enablement of

ulnar/median paralyzed thumb in leprosy[53].

Methta et al‟s study in 1996 compares two different opponensplasties either extensor

indicis proporis (EIP) transfer plus radial half of flexor pollics longus (FPL) or flexor digitorum

superficialis (FDS) from the ring or middle finger. In hands where EIP and FPL were used (2

tendon transfer) overall satisfactory results were seen in 93%. Plus points for this choice of

operation were that all cases gained enough strength to reposition the thumb, there was no

requirement for a tendon graft to elongate the tendon and there was very little re-educating

of the patient required for good functional results.

In FDS transfer the overall satisfactory results where 66%. Complications for both

techniques listed in appendix 1. The author‟s highlight that incidence of postoperative

complications correlate with overlooked preoperative hand dysfunction for example stiffness

or contractures were present in 3 out of 4 thumbs having poor results. The authors conclude

that where two tendons were transferred (EPI and FPL) the outcome was better than FDS

transfer with two insertions extrapolating that this is due to the complex movement

opposition requires. They further state that in leprosy cases where combination nerve

palsies exist surgical outcomes are not as good as in single nerve paralysis however this

statement is not backed up by the evidence given and is based upon the authors findings in

practice not on a statistically significant finding from the study.

Opponensplasty by Extensor Indicis (EI) or FDS Tendon Transfer[54].

Anderson et al conducted a study comparing the results of opponensplasty using

either EI or FDS. EI group had 98% excellent and good results and the FDS group have

85% excellent and good, both having about 2% poor results. The conclusion drawn by the

authors were that the use of EI in thumb reanimation produced better results in supple

24

hands while the more powerful FDS tendon transfer was better in stiffer hands, however

again this conclusion seems to be based on personal opinion. The study does not actually

identify those with stiffer hands compared to those without undergoing the different

operations; hence it is difficult to ascertain the applicability of the studies to the wider leprosy

affected population.

Quality of studies included.

The quality of the studies reviewed where generally poor. Of the studies looking at

claw hand correction only three (Ozkan et al, Malaviya and Taylor et al) compared different

surgical techniques. Studies by Brandsma et al and by Brand compared pre and

postoperative function. All the papers had well defined clinical questions and all except one

(Brandsma et al) adequately described the surgical technique(s) employed. Where surgical

techniques where compared no patient randomization occurred.

In Ozkan et al‟s study there was no indication of how the patients were assigned to

their treatment group. The demographic of the patient groups did appear to be similar for

age sex and mean follow up time however there was a statistically significant difference in

the time at which the palsy had been present in the groups (P=0.03). This could significantly

add to study bias producing erroneous results.

Malaviya‟s study in 2003 also compared different techniques but again did not give

any indication of patient assignment resulting in possible selection bias. There was no

indication that group demographics where recorded and that chance could not have lead to

unacceptably large differences in the base line features. Taylor et al‟s study comparing two

different surgical techniques used retrospective data and didn‟t indicate the basis of surgical

group assignment.

Of the three follow up studies using pre and post operative out comes as

comparisons none of them made any comparison to patients undergoing conservative or

any other treatment so it‟s hard to draw conclusions as to what exactly lead to

improved/worsened outcomes. Only one paper by Brand in 1958 gave details as to case

selection for surgery and for follow up. Follow up was based on geography, likely to give

selection bias however there was an attempt to compensate for this by doing a smaller

thorough follow up in one area and compare demographics and outcomes with patients

selected by geography.

Only Ozkan et al attempted any sort of statistical analysis beyond simple comparison

of percentages using analysis of variance (ANOVA) for comparison of quantitative variables

and the qui squared test for comparison of categorical variables. None of the studies

attempted to blind the assessors and often it was a member of the surgical team that

25

assessed the outcome creating problems of reporter bias. Only one study by Taylor

indicated that a physiotherapist “not attached to the surgical team” did the postoperative

assessment.

Malaviya reported two patients lost to follow up. Brands study in 1958 requested

review of 184 patients with a response of 112 patients, reasons such as poverty, inability to

read and write and change of address quoted as affecting follow up. Brandsma was only

able to follow up 45% of the patients operated on. None of the other studies documented

losses to follow up which would affect validity of results.

Most of the studies mentioned postoperative intervention. The standard for this was

between 2 and 4 weeks of immobilization in the majority of cases followed up by

physiotherapy, and in one study occupational therapy (Anderson 1992). The one study

found directly looking at postoperative intervention was a small randomized controlled trial

comparing immediate activity with immobilization after claw hand repair. The study used

mixing of opaque envelopes containing allocation details in a box for randomization. This

method is poor and prone to error but made an attempt at reduction in selection bias. Follow

up was conducted by therapists not involved in earlier care and blinded to postoperative

technique used hence controlling of reporting bias. Demographic details of the two groups

where analyzed attempting to identify if chance could have affected results; this did not

appear to be a problem.

Studies identified looking at opponensplasty again where very variable and often

poor. Three of the four studies compared different operative techniques (Patond et al, Mehta

et al and Anderson et al) but none of these were randomized controlled trials. The study by

Patond et al was small and analyzed results of thumb correction in 37 operations. 7 patients

were lost to follow up. The paper gave clear inclusion criteria but the allocation of surgical

technique was based upon type of paralysis so the results are not comparable between

grups. Like all the studies looking at opponensplasty there was good documentation of the

operation(s) performed. The use of arbitrary divisions in to good fair and poor (and

sometimes excellent as well) was commonly used (Brandsma et al, Mehta et al, Brand and

Anderson) but these all had different contributing objective and subjective measurements so

were non-comparable. These arbitrary divisions are also open to interpretation and error in

use and therefore give results difficult to apply to other patient groups.

A much larger study done by Schwarz assessed 156 opponensplasties. This was a

retrospective study and used patient notes to look at operative outcomes. Retrospective

studies are inherently flawed, as they can only be as good as the documentation they are

based on and are open to the bias of those that write and those that review the notes. 14

notes were also missing or incomplete adding to the bias of the study. Some operations

26

used within the analysis where also re-do‟s (156 operations on 137 hands) giving a false

impression of outcome.

The study by Anderson et al though larger and conducted on patients at follow up

had flaws. There was no blinding of the allocation process and no indication in the study as

to how patients were allocated to operations. Base line differences were recorded in the

subgroups and in one group there was a discrepancy of 5 years in average participant age

that could have adverse affect on results. No indication of assessor blinding is given leaving

another source of bias. The patient‟s opinion was not sort in this trial (and many others) and

as patient satisfaction is an important predictor for good surgical outcome this is another

area lacking. This study also included a small numbers of patients who did not have leprosy

(trauma, polio, burns and congenital causes) this could affect the studies applicability to

leprosy.

Overall study quality was poor. Study power is often insufficient and there is little

attempt to correct for selection or assessor bias or for chance. The studies are all open to

type 1 and type 2 errors and many contain personal views as conclusions. Mostly, apart

from very basic percentage comparisons, statistical analysis was not used and due to the

varying ways and stratification techniques done for outcome measures compilation of data to

increase power couldn‟t be achieved.

Study Heterogeneity.

Studies included where very heterogenous. Eight studies were done in India two in

Ethiopia, one in Nepal and one in Turkey. Age groups, the length of time that paralysis had

been present and presence of secondary problems were widely variable. The type of leprosy

was only occasionally documented (Patond et al, Sundararaj et al) different classification

systems were used, having implications for results. Pre and postoperative care also varied

some undergoing intensive preoperative physiotherapy (Patond et al, Brandsma et al) or

surgery for contractures. Some had no preoperative care and some studies excluded those

with contractures altogether (Rath Ozkan et al and McEvitt et al). The experience and skill of

the surgeons also plays a role in affecting outcomes. Only one study by Malaviya provided

the information that all operations where done by the same surgeon. Outcome measures

were variable some very simple and some sophisticated using photographs and

dynamography (Malaviya) again affected comparison between the different studies.

27

According to present literature what is the most effective surgical interventions for

management of stable upper-limb paralysis?

All studies reported on mechanical function (such as finger angles and fist formation)

and reported overall improvement post-operatively. In those papers where two operations

where compared with one another Ozkan et al, Malaviya and Taylor for claw hand

correction, Patond, Mehta and Anderson for opponensplasty and Rath et al for post

operative care. The large differences in choice of operation/intervention, technical aspects of

the operations, the operative skill of the surgeon, differences in patients involved, length of

time to follow up and outcome measures make comprehensive comparisons and assimilated

conclusions impossible.

Interventions most affective at improving quality of life or stigma?

None of the papers looked directly at or measured improvement in quality of life or

related stigma. Measurement of functional skills such as ability to manage appropriate

activities of daily living was attempted by Brand using graded cylinders simulating use of

tools. This had to be abandoned due to patients learning to improve scores by dampening

their hands and increasing grip by friction, all the other studies used mechanical

measurements. Patond et al and Taylor et al did ask the patient if there had been an

improvement in their daily functioning but this was not quantified by an examination, no other

assessment of daily activity was attempted.

Acceptability to patients of surgery/inpatient time was not assessed in any of the

papers. None of the studies assessed the cost effectiveness of surgical intervention(s). The

cost to the patient including travel, time off work, and educational loss for those school age,

was also not evaluated in any paper. Rath et el mentions that early active mobilization may

save expense but does not go on to quantify this. Similarly Patond et al comments that one

stage correction of fingers and thumb in combined nerve paralysis may lead to earlier return

to work but this is not further explored.

Any adverse events/unwanted side effects of surgery?

A variety of adverse events were documented in the papers chosen for this review.

All of the papers except one by Brandsma et al gave specific complications related to the

operative technique used. Several of the papers noted that deformities could occur in the

FDS donor finger for claw or simian thumb correction. These included distal inter-phalangeal

(DIP) and proximal inter-phalangeal (PIP) flexion contractures (Check rein deformity) (Ozkan

et al, Malaviya, Anderson, Mehta et al, Patond) this is a well known complication and

Brandsma et al in 1992 wrote a paper on long term follow up and occurrence of adverse

28

events in the FDS donor finger[55]. Patond also reported this deformity in fingers using

extensor indicies (EI) transfer though Anderson reported no such complications with EI use.

Infection was an early complication mentioned in a few studies that lead to

significantly poorer results (Brand 61, Oberlin, Schwarz et al). Swan neck deformity (hyper

extended PIP joint and a flexed DIP joint) occurred in Ozkan et al‟s study using FDS but also

in Taylor‟s study using Palmaris longus the reason proposed being excessive tension at the

transfer. A complication quoted for the use of ECRL was ulnar deviation (Malaviya) and

Taylor comments that his study should have included testing for this along with wrist

extension power to look for defects second to ECRL‟s transfer. Other complications inherent

to most hand surgery such as stiffness, skin necrosis or suture breakdown are sporadically

mentioned[56].

Median nerve damage second to surgery occurred in one study (Malaviya, et al)

though rare the implications for iatrogenic nerve damage lead Brandsma et al in 1985 to look

at if there is an increase in median nerve damage after tendon transfer. His findings where

that there is no association[56]. Further studies looking at adverse events have been written

and suggestions on how to avoid complications are in much of the literature[57-59].

Is immediate physiotherapy better than immobilization after surgery in leprosy related

paralysis?

Many of the studies highlighted the importance of postoperative training and

physiotherapy of the patient (Taylor et al, Mehta et al and Brand). Preoperative function was

noted by several authors to be an important predictor of postoperative outcome (Ozkan et al,

Mehta et al Brandsma et al and Brand).

The one trial by Rath et al suggests that immediate mobilization is preferable to the

conventional postoperative immobilization in plaster. This study is based on only 50 patients

however and will need further larger studies before it can be accepted in to current practice.

29

Discussion and Recommendations

Leprosy can lead to disability in two ways. Primary

disability comes from the direct sensory and motor dysfunction

leading to the paralyzed and insensate hand. This can lead to

secondary disabilities from joint contractures and tissue loss;

second to trauma infection and inappropriate limb use[37].

Once primary disability has developed early and affective

educational and surgical management of affected hands can

prevent development of irreversible secondary deformities and

disabilities.

Of all deformities in leprosy 80% require minor surgery

and the rest major surgery[60]. Tendon transfer is the only option available in cases of

deformities like simian thumb, claw hand, and wrist drop[61]. At present we can only correct

the motor component and that only to an extent. Sensory loss and its dangers continue and

care in the management of the anesthetic part via patient education and tools is essential to

maintain integrity of any restored digits[52]. Early attempts have been made to surgically

correct sensation in the hand recognizing that this could not only prevent disability but also

decrease development of secondary disabilities. None of the pioneering techniques have so

far made the transfer in to common use [62-64].

The studies that I have discussed looking at surgical options for the leprosy affected

hand have helped shape current practice. These have increased the knowledge base on

outcomes for these patients. In some of the studies where there was comparison of different

techniques this provided reference for those faced with choosing the best operative

procedure. These studies have helped guide surgeons, disseminate information on new and

evolving practices and highlight postoperative complications and pitfalls. However the

evidence base for current surgical practice in these patients is weak. This is due to a number

of problems with research that has been conducted on leprosy surgery.

The studies looked at in this paper are often small not controlled or blinded and use a

host of pre post and inter-operative techniques making assimilated conclusions difficult. The

different inclusion and exclusion criteria for the trials and the great variability in the outcome

measures used make over reaching conclusions impossible. The lack of assessment and

documentation of how “every day” function is improved, or not postoperatively means that

relevance to the patient‟s daily living is not easily elucidated. There is also almost no

documentation of affects on stigma or other aspect of the patent‟s lives such as relief of

financial or relationship burdens. These are areas that the WHO is keen to highlight in the

Figure 8. Tool used to improve hand function.

30

more holistic initiatives of long-term disability management in leprosy and that future surgical

trials may need to attempt to assess more adequately.

The areas that the studies mostly do seem to agree on are that preoperative function

is an important predictor of surgical result. That physiotherapy appears to be an important

factor in producing good outcomes and that the different operations used can produce

multiple different complications but that overall function is improved.

Future Research

The lack of consistency and great variability in outcomes and techniques in surgical options

for upper limb paralysis in leprosy would suggest that further rigorous and controlled trials

which conform to current standards for design and reporting are greatly desirable to guide

best evidence based practice for care of leprosy patients with disabilities. The structure,

requirements and pitfalls for a trial are discussed in appendix 2.

31

Correction claw hand

Study type Study

duration Country /setting

Inclusion criteria

Exclusion criteria

Number in study

(number operations)

Mean age

Disabilities duration

(mean time paralysis)

Operation performed

Controll/ comparison

group(s)

Postoperative interventions

Outcome measures Complications

Ozkan et al 2003[30]

Follow up study

6-120 months follow up (avareage 56 mths)

Turkey, Outpatients

Ulnar nerve palsy and claw hand 2

nd to

leprosy.

Patients with joint contractures

25 patients (25 hands)

36 years (range 21-57)

FDS-4T a

procedure= 103 mths. ZLP

b=

68mths. (Avareage 97mths)

19 FDS-4Ta

(12male 7female)

6 ZLPb

(3male 3female)

4 week immobilization

Grip strength. ROMc

at PIPJd sequence

of phalangeal flexion, open + closure of hand.

Swan neck deformity

e .

Felexion contractures.

Malaviya 2003[33]

Retrospective study

3 mths to 12.5 years (mean 4.5 years)

India Outpatients.

Ulnar/ ulnar plus median nerve palsy and claw hand 2

nd to

leprosy

Patients with joint contractures not corrected by physio/ splinting.

63 patients (65 hands) 56men 7women.

(Range 14-53)

29 mths 4 talied lasso procedure. Using either 1)FDS1

f (23)

2)FDS2g

(10) 3)PL

h (18)

4)ECRLi (12)

(number of patients)

Nil Not recorded Stiffness, normal finger closure pattern, movement intergration, span of hand, grip strength, stable tripod pinch, improved asthetics. Finger dynamography.

Stiffness, poor flexion, digit ulnar deviation. PIPJ

d

contracture PIPJ

d hyper

extension. DIPJ

j flexion.

Median palsy. Adhesions in palm.

Taylor et al 2004[31]

Follow up study

33 mths mean follow up

India Outpatients.

Ulnar nerve palsy and claw hand 2

nd to

leprosy.

Stiffnes or joint contracture after pre-op physio therapy. Hyper-mobile hand.

55 patients (65 affected hands) 50male 15female.

EF4Tk 26

(range 13-45) PL4T

l 26

(range 13-53)

EF4Tk 2.8

years(0.5-8) PL4T

l 3.6

years (0.5-9)

40 PLh 4

tailed tendon transfer opperations.

25 EF4Tk

tendon transfer using ECRL

i

3 weeks immobilized. 3 weeks postopperative physical therapy and patient re-education.

Angle measurments, 5 standadized positions photographed. Mechanical function. Patient satisfacation.

Hoodingm,

swan neck deformity

e,

extension limitation, flexion limitation.

Brandsma et al 1982[43]

Follow up study

4.8 years (range 1-11 years)

Ethiopia Outpatients

Claw hand 2

nd to

leprosy. All under went pre-op physio.

Not recorded


Not recorded

8-18 age group 2.2 years. 19-25 age group 3 years and 26-43 age group 4 years

Extensor to flexor transfer with ECRL

i or

extensor carpi radialis brevis (ECRB)

FDSn

transfer Physiotherapy and re-education.

Comparison of younger and older patients. Active extension of fingers. Improvement in patients with contractures. Grip- measrure by contact of fingers segments on a cylinder.

Not recorded.

Appendix 1; detailed description of studies.

32

Brand 1958[45]

Follow up study

Not recorded.

India Outpatients.

Ulnar, ulnar/median nerve palsy and claw hand 2

nd to

leprosy and geographically close.

Paralysis of < 6 mths. Open wounds on limb. Stiff joints nonamenable to physio or grafting. Operations before 1950.


Not recorded

Not recorded

FDS transfer

n

Postoperative compared to preoperative.

Not recorded. ROMc at IP

s joints.

Hands photographs in six positions. Correct proximal to distal finger closure. Patients opinion. Grouped Excellent, good, fair and poor.

Intrinsic plus deformity

p.

Lateral deviation of fingers. Bow stinging of tendon across MCP

q joint.

Grasp/pinch weekness. Worsened post operative contractures.

Brand 1961[44]

Follow up study.

2 years India Outpatients.

Ulnar, ulnar/median nerve palsy and claw hand 2

nd to

leprosy.

Contracture non responding to physio or splinting


Not recorded

Not recorded.

Extensor carpi radialis brevis (ECRB)

Post operative function compared to pre operative.

Post op physiotherapy.

ROMc at

interpalengeal joints. Photographs of hands in six positions. Correct proximal to distal finger closure. Patients opinion. Grouped Excellent, good, fair and poor.

Infection.

Post operative interven

tion

Study type Study


Inclusion criteria

Exclusion criteria

Number in study

(number operations)

Mean age



Operation performed


group(s)



Rath, S. 2008[47]

Prospective study (GroupA) compared to retrospective data (GroupB)

21 days post op

India In and outpatinets

Ulnar nerve paralysis 2

nd to

leprosy of 1 year or more. Completed MDT

r

Joint contracture. Extensor damage. FDS

n tendon

unsuitable. Loss of digits. Neuropathic joints

63 patinets (64 hands)

GroupA 27 S.D.

z

10.79 GroupB 31 S.D.

z

13.14.

GroupA 5.5 years S.D

z 3.70.

GroupB 4.2 years S.D.

z 3

FDS-4Ta GroupA

immediate mobalisation. GroupB 3 weeks immobilisation then mobalisation

Immediate active mobalisation or 3 weeks immobilization then mobalisation.

1) Tendon detachment. 2)Clawing in open hand and intrinsic plus deformity

p.

3) Post op morbidity

1) Tendon detachment. 2)Clawing in open hand and intrinsic plus deformity

p.

3) Post op morbidity

33

Simian thumb

correction

Study type Study


Inclusion criteria

Exclusion criteria

Number in study

(number operations)

Mean age



Operation performed


group(s)



Schwarz et al 2003[48]

Retrospective study

Avarage follow up 20 mths range (1-108 mths)

Nepal Audit of notes.

All opponensplastie 1987-97 at Anandaban Hospital.

14 incompleat/ missing records.

115 patients (156 hands) 85%male 15%female

30 Not documented.

FDSn

opponensplasty. Primary FPL

t 2%.

Revision FDS

n 9%

Revision FPL

t 3%

Patinets having revised plastys. Patients having concomitant claw corrections. Patients 50+.

Immobilisation 3 weeks then physiotherapy.

Pre and post op. Finger to which thumb could obtain pintch grip and gap between thumb and MCP

q joint.

Patient satisfaction.

7 early complications- infection, terminal thumb necrosis or skin necrosis. 16 late complications z thumb

u and

1 other.

Patond et al 1999[34]

Follow up study

Avarage 19mths

India Outpatients.

Median nerve paralysis patients undrgoing/gone MDT

r. Pre

op physio correcting contractures.

Paralysis of < 6mths. < 6 mths MDT

r

compleated. Leprosy reactions. Web relaese /arthrodesis needed.


39 years (range 18-60)

6 mths to 5 years.

FDSn

transfer. Extensor indices proprius (EIP) in high ulnar paralysis.

Immobilization 4-6 weeks. Then flexion/ extension of fingers encouraged.

1) Results graded. Good, fair, poor based on 3 finger pintch pattern. 2) Patinet satisfaction with functional improvement.

7 patients lost to follow up (all from FDS

n

group). Swan neck deformtiy

e.

Check renino

deformity.

Mehta et al 1996[49]

Follow up study

1-3 years India. Outpatients

Subsided disease. Median, median/ ulnar palsy due to leprosy.

Nil recorded 20 patients (23 hands) (16 male 7 female)

(range 12 to 45)

1 to 3 years FDSn

transfer in 9 patients. 2 slip insertion.

Extensor indicis proporis (EPI) transfer or radial half of flexor pollicis longus done in 14 patients.

Nil recoded Results grouped good fair and poor.

PIPJd flexion

contractures DIPJ

j flexion

contractures. Loss of independent extension at MCP joint.

Anderson 1992[51]

Follow up study

FDS 4v

(lateral insertion) 29.3mths FDS 4

v

(volar insertion) 24.2 mths EI

w 30.8

India. Outpatients.

Median, median/ ulnar palsy due to leprosy Operated on 1977-88.

No improvement with preoperative physiotherapy.


FDS 4v

(lateral insertion) 30.1years FDS 4

v

(volar insertion) 30.2years EI

w

25.4years

Not recorded.

FDS 4v

(116). Lateral insertion (74) or volar insertion (42) of tendon.

EIw

(50) Immobilization 3 weeks. After physiotherapy and re-education (2 weeks). Occupatonal therapy for one week.

MRCx grading,

sensory testing with mono-filaments and cotton wool. Mobility stability and angles of joint contracture. Digit absorption. Categorised; excellent, good, fair, poor.

14 patients lost to follow up. Extension and flexion limitation contracture of PIPJ

d in FDS

n

donor finger.

34

a) FDS 4T- Flexor digitorum superficialis 4 tailed procedure b) ZLP- Zancollis lasso procedure- flexor superficialis tendon sutured to it‟s self in palm of hand forming a lasso around the fingers MCP pully. c) ROM- Range of movement d) PIPJ- Proximal interphalangeal joint e) Swan neck deformity describes a finger with a hyper extended PIP joint and a flexed DIP joint. f) FDS1- Flexor digitorum superficialis form index finger g) FDS2- Flexor digitorum superficailis from middle finger h) PL- Palmaris longus i) ECRL- Extensor carpi radialis longus j) DIPJ- Distal interphalangeal joint k) EF4T- Extensor to flexor 4 tailed tendon transfer l) PL4T- Palmaris longus 4 tailed tendon transfer m) Hooding- flexion at PIP and hyperextension at DIP n) FDS- Flexor digitorum superficialis o) Check-renin deformity is defined as a post-operative rigid flexion contracture of the PIP joint. p) Intrinsic plus deformity fixed flexion at the metacarpophalangeal joints. q) MCP- metacarpophalangeal joints r) MDT- Multi drug therapy s) IP- Interphalangeal joint t) FPL- Flexor pollisus longus u) Z thumb- hyperextension of the interphalangeal joint and fixed flexion and subluxation of the metacarpophalangeal joint. v) FDS4- Flexor digitorum superficialis form little finger w) EI- Extensor indicies x) MRC- Medical research council z) S.D – Standard deviation

35 of 52

Appendix 2; Research project.

Areas requiring further trials include;

1) Best operative management of the claw hand in the stiff and supple hand.

2) Best operative management of correction of the simian thumb.

3) Best operative management of those with combined ulnar and median nerve

paralysis.

4) Best postoperative management of patients undergoing surgery on the leprosy

affected hand.

Randomized double blind placebo controlled trials are the ideal though these are

inherently difficult to achieve in surgical management. Randomization of treatment arm

allocation should be achieved using computer generated random numbers, which assign a

participant to a group eliminating selection bias. Blinding of both patient and of physician is

preferred but this is only possible up to a point with the surgeon required to perform the

operation. Assessors of outcome however should be blinded and be independent of the

surgical team so as to not have a vested interest. The use of placebo in surgery can be

achieved using “sham operations” but this is often un-ethical and difficult to perform. All

studies must be ethically approved and advantageous to participants.

Studies need to be adequately powered allowing for statistically significant results to be

obtained. For a disease such as leprosy with relatively few surgical procedures carried out in

each centre a multi center study would be appropriate including individuals from many

countries and treatment in many health care facilities by many different surgeons. Inclusion

and exclusion criteria need to be well specified and adhered to through all the different

centers. Once a hypothesis has been stated data needs to be appropriately statistically

analyzed and the hypothesis proved or refuted. Data should be analyzed with patient‟s

intention to treat.

Write up of studies should conform to the CONSORT statement (Consolidated Standards of

Reporting Trials) which encompasses various initiatives developed by the CONSORT Group

to alleviate the problems arising from inadequate reporting of randomized controlled

trials[65]. Adequately produced randomized controlled trials allows for future meta-analysis

such as those registered with the Cochrane database.

36 of 52

Acknowledgements

I would like to thank Donald Sammut for his generous help. James Mackie for his support,

Lilli Cooper for her encouragement and Natasha Hezalgrave for the cups of tea.

References.

1. WHO. Leprosy today. 2010 [cited 2010 22 June 2010]; Available from: http://www.who.int/lep/en/.

2. Britton, W.J. and D.N.J. Lockwood, Leprosy. Lancet, 2004. 363(9416): p. 1209-19. 3. Lockwood, D.N., Leprosy elimination-a virtual phenomenon or a reality? BMJ,

2002. 324(7352): p. 1516-8. 4. Sharma, R., Complete elimination of leprosy still elusive. BMJ, 2001. 322(7282): p.

318e-. 5. World Health Organization Regional Office for South-East Asia New, D., Global

strategy for further reducing the leprosy burden and sustaining leprosy control activities 2006-2010. Operational guidelines. Leprosy Review, 2006. 77(3): p. IX.

6. WHO, Enhanced Global Strategy for Further Reducing the Disease Burden Due to Leprosy

Operational Guidelines (Updated) (2011-2015). 2009, WHO Regional Office of South East Asia. 7. Wilder-Smith, E.P. and W.H. Van Brakel, Nerve damage in leprosy and its

management. Nat Clin Pract Neurol, 2008. 4(12): p. 656-63. 8. Bryceson, A.P., R. E., Leprosy. 3rd ed. Medicine in the Tropics. 1990, Edinburgh

London Melbourne and New York: Churchill Livingstone. 9. Hastings, R.C., Leprosy. 2nd ed. Medicine in the tropics series. 1994, Edinburgh

New York Churchill Livingstone. 10. Gill, G.B., N., Lecture notes Tropical Medicine. 2009, Wiley Blackwell. p. 171-184. 11. Parry, E.G., R. Mabey, D. Gill, G., Principles of Medicine in Africa. 3rd ed. 2004,

Cambridge: Cambridge University Press. 12. Van Brakel, W.H., et al., The INFIR Cohort Study: Assessment of sensory and motor

neuropathy in leprosy at baseline. Leprosy Review, 2005. 76(4): p. 277-295. 13. Van Brakel, W.H., et al., The INFIR Cohort Study: Investigating prediction, detection

and pathogenesis of neuropathy and reactions in leprosy. Methods and baseline results of a cohort of multibacillary leprosy patients in North India. Leprosy Review, 2005. 76(1): p. 14-34.

14. Murthy, P.K., Clinical manifestations, diagnosis and classification of leprosy. Journal of the Indian Medical Association, 2004. 102(12): p. 678-9.

15. Goulart, I.M. and L.R. Goulart, Leprosy: diagnostic and control challenges for a worldwide disease. Arch Dermatol Res, 2008. 300(6): p. 269-90.

16. Sarkar, K., Corrective surgery for deformities in women leprosy patients. Indian Journal of Leprosy, 2004. 76(3): p. 233-5.

17. Ridley, D.S. and W.H. Jopling, Classification of leprosy according to immunity. A five-group system. International Journal of Leprosy & Other Mycobacterial Diseases, 1966. 34(3): p. 255-73.

18. Khambati, F.A., et al., Sensitivity and specificity of nerve palpation, monofilament testing and voluntary muscle testing in detecting peripheral nerve abnormality,

http://www.who.int/lep/en/

37 of 52

using nerve conduction studies as gold standard; A study in 357 patients. Leprosy Review, 2009. 80(1): p. 34-50.

19. Mehndiratta, R.C., et al., Does nerve examination improve diagnostic efficacy of the WHO classification of leprosy? Indian Journal of Dermatology, Venereology & Leprology, 2008. 74(4): p. 327-30.

20. Banerjee, S., et al., Development and application of a new efficient and sensitive multiplex polymerase chain reaction (PCR) in diagnosis of leprosy. Journal of the Indian Medical Association, 2008. 106(7): p. 436-40.

21. WHO, WHO Expert Committee on Leprosy. World Health Organ Tech Rep Ser, 1998. 874: p. 1-43.

22. Van Veen, N.H.J., et al., Decompressive surgery for treating nerve damage in leprosy. A Cochrane review. Leprosy Review, 2009. 80(1): p. 3-12.

23. Saunderson, P., The epidemiology of reactions and nerve damage. Leprosy Review, 2000. 71(SUPPL): p. S106-S110.

24. Saunderson, P., et al., The pattern of leprosy-related neuropathy in the AMFES patients in Ethiopia: Definitions, incidence, risk factors and outcome. Leprosy Review, 2000. 71(3): p. 285-308.

25. Smith, W.C.S., et al., Steroid prophylaxis for prevention of nerve function impairment in leprosy: Randomised placebo controlled trial (TRIPOD 1). British Medical Journal, 7454. 328(7454): p. 1459-1462.

26. Schuring, R.P., et al., Protective effect of the combination BCG vaccination and rifampicin prophylaxis in leprosy prevention. Vaccine, 1999. 27(50): p. 7125-8.

27. Srinivasan, H., Nerve damage, surgery and rehabilitation in leprosy. Tropical Medicine and Parasitology, 1990. 41(3): p. 347-349.

28. Srinivasan, H., Algorithms as guides for the prevention of permanent nerve damage in leprosy patients. Indian Journal of Leprosy, 2004. 76(4): p. 321-324.

29. Meima, A., et al., Factors associated with impairments in new leprosy patients: The AMFES cohort. Leprosy Review, 1999. 70(2): p. 189-203.

30. Van Veen, N.H.J., A. Meima, and J.H. Richardus, The relationship between detection delay and impairment in leprosy control: A comparison of patient cohorts from Bangladesh and Ethiopia. Leprosy Review, 2006. 77(4): p. 356-365.

31. Smith, W.C.S., et al., Predicting neuropathy and reactions in leprosy at diagnosis and before incident events - Results from the INFIR cohort study. PLoS Neglected Tropical Diseases, 2009. 3(8).

32. Smith, W.C.S., Review of current research in the prevention of nerve damage in leprosy. Leprosy Review, 2000. 71(SUPPL): p. S138-S145.

33. Brakel, D.W.H.v. Current practices in disability grading and monitoring. 2009 [cited 2010 7th July]; Lacture notes]. Available from: http://www.ilep.org.uk/fileadmin/uploads/Documents/WHO_TAG_Meetings/Informal_Consultations_G2D_and_Chemoprophylaxis/Current_Practices_in_G2D_Assessment_and_Monitoring.pdf.

34. The SALSA Collaboative Study Group. Ebenso, J.F., P. Melchior, H. Wexler, R. Shumin, C. Piefer, A. Premkumar, R. Benbow, C. Nicholls, P. Velema, J. Saunderson, P. Lehman, L. SALSA Beta Testing Package. 2004 Web page [cited 2010 9th July]; Available from: http://www.ilep.org.uk/fileadmin/uploads/Documents/Infolep_Documents/Salsa/Beta_Testing_Package_V1.0_S.pdf.

35. WHO’s Classification, T.a.S.T.C. and w.t.f.o.t.W.N.J.P.o.A.a.C.o. Disability. WORLD HEALTH ORGANIZATION

http://www.ilep.org.uk/fileadmin/uploads/Documents/WHO_TAG_Meetings/Informal_Consultations_G2D_and_Chemoprophylaxis/Current_Practices_in_G2D_Assessment_and_Monitoring.pdf



http://www.ilep.org.uk/fileadmin/uploads/Documents/Infolep_Documents/Salsa/Beta_Testing_Package_V1.0_S.pdf

http://www.ilep.org.uk/fileadmin/uploads/Documents/Infolep_Documents/Salsa/Beta_Testing_Package_V1.0_S.pdf

38 of 52

DISABILITY ASSESSMENT SCHEDULE 2.0. [Web site] 2009; Available from: http://www.unescap.org/stat/disability/census-ws/WHODAS-English.pdf.

36. (AAOS), D.b.t.I.f.W.H.a.t.A.A.o.O.S. DASH "Disabilities of the Arm, Shoulder and Hand." Outcome measure. 2009 [cited 2010 9th July]; Available from: http://www.dash.iwh.on.ca/.

37. Ozkan, T., et al., Surgical reconstruction of irreversible ulnar nerve paralysis in leprosy. Leprosy Review, 2003. 74(1): p. 53-62.

38. Taylor, N.L., et al., The correction of ulnar claw fingers: a follow-up study comparing the extensor-to-flexor with the palmaris longus 4-tailed tendon transfer in patients with leprosy. Journal of Hand Surgery - American Volume, 2004. 29(4): p. 595-604.

39. Moberg, E.G., S., Emergency Surgery of the Hand. 1967, Edinburgh and London: E & S Livingstone Ltd.

40. Roy, C., N.C. Nath, and S.R. Saha, Reconstructive surgery in upper limbs in leprosy. Journal of the Indian Medical Association, 2004. 102(12): p. 702-3.

41. Malaviya, G.N., Comparative evaluation of effectiveness of different motor muscles in modified lasso procedure for correction of finger clawing. Journal of Hand Surgery - British Volume, 2003. 28(6): p. 597-601.

42. Sundararaj, G.D. and K. Mani, Surgical reconstruction of the hand with triple nerve palsy. Journal of Bone and Joint Surgery Series B, 1984. 66(2): p. 260-264.

43. McEvitt, E. and R. Schwarz, Tendon transfer for triple nerve paralysis of the hand in leprosy. Leprosy Review, 2002. 73(4): p. 319-25.

44. Brandsma, J.W. and T. Lijftogt, Timing of tendon-transfer surgery. Leprosy Review, 1983. 54(2): p. 109-114.

45. Reinar Liv, M., et al., Interventions for skin changes caused by nerve damage in leprosy. Cochrane Database of Systematic Reviews: Reviews, 2008(3).

46. Palande, D., Correction of paralytic claw finger in leproy by capsulorrhaphy and pully advancement. Journal of Bone and Joint Surgery Series A, 1976. 58A(1): p. 59-66.

47. Brandsma, W., Claw finger correction; Results of extensor flexor many tailed opperation. The Hand, 1982. 14(3): p. 307-312.

48. Brand, P.W., Tendon Grafting. The Journal of Bone and Joint Surgery, 1961. 43B(3): p. 444-453.

49. Brand, W., P., Paralytic claw hand. The Jounal of Bone and Joint Surgery, 1958. 40B(4): p. 618-632.

50. Rath, S., et al., A randomized clinical trial comparing immediate active motion with immobilization after tendon transfer for claw deformity. The Journal of hand surgery, 2009. 34(3): p. 488-94, 494.el-5.

51. Schwarz, R.J. and M. Macdonald, Assessment of results of opponensplasty. Journal of Hand Surgery - British Volume, 2003. 28(6): p. 593-6.

52. Patond, K.R., B.D. Betal, and V. Gautam, Results of thumb correction in leprosy using different techniques. Indian Journal of Leprosy, 1999. 71(2): p. 155-66.

53. Mehta, R., et al., Single tendon-two insertion versus two tendon transfers for reablement of ulnar-median palsied thumb in leprosy. Acta leprologica, 1996. 10(2): p. 105-109.

54. Anderson, G.A., V. Lee, and G.D. Sundararaj, Opponensplasty by extensor indicis and flexor digitorum superficialis tendon transfer. Journal of Hand Surgery - British Volume, 1992. 17(6): p. 611-4.

http://www.unescap.org/stat/disability/census-ws/WHODAS-English.pdf

http://www.dash.iwh.on.ca/

39 of 52

55. Brandsma, J.W. and M.W. Ottenhoff-De Jonge, Flexor digitorum superficialis tendon transfer for intrinsic replacement. Long-term results and the effect on donor fingers. Journal of Hand Surgery - British Volume, 1992. 17(6): p. 625-8.

56. Brandsma, J.W. and P.W. Brand, Median nerve function after tendon transfer for ulnar paralysis. Journal of Hand Surgery - British Volume, 1985. 10(1): p. 30-2.

57. Malaviya, G.N., Unfavourable results after surgical correction of claw fingers in leprosy. Indian Journal of Leprosy, 1997. 69(1): p. 43-52.

58. Malaviya, G.N., Some more about unfavourable results after corrective surgery as seen in leprosy. Indian Journal of Leprosy, 2002. 74(3): p. 243-257.

59. Malaviya, G.N., Median nerve palsy following claw finger correction in leprosy: Effect of M. Leprae or a consequence of surgery. Indian Journal of Leprosy, 2002. 74(3): p. 217-220.

60. Virmond, M. and H. Da Rosa Pereira, Surgical correction of deformities and disabilities in leprosy patients. Indian Journal of Leprosy, 2000. 72(3): p. 401-412.

61. Agrawal, A., et al., Leprosy, nerves, and surgery. Infectious Diseases in Clinical Practice, 2008. 16(6): p. 345-348.

62. Ganopol, J., M. Antola, and M.C. Ortiz, Neuropathy in leprosy: Results of surgical treatment. International Journal of Leprosy, 1979. 47(2 Sup).

63. Pereira, J.H., et al., Nerve repair by denatured muscle autografts promotes sustained sensory recovery in leprosy. Journal of Bone and Joint Surgery Series B, 2008. 90(2): p. 220-224.

64. Ozkan, T., K. Ozer, and A. Gulgonen, Restoration of sensibility in irreparable ulnar and median nerve lesions with use of sensory nerve transfer: long-term follow-up of 20 cases. Journal of Hand Surgery - American Volume, 2001. 26(1): p. 44-51.

65. CONSORT, G. The CONSORT statement. 2010 [cited 2010 17/8/10]; Web page]. Available from: http://www.consort-statement.org/consort-statement/overview0/.

http://www.consort-statement.org/consort-statement/overview0/

http://www.consort-statement.org/consort-statement/overview0/

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London School of Hygiene & Tropical Medicine (University of London)

Combined Academic, Risk assessment and Ethics (CARE) approval form for MSc Project Reports

*This form must be completed electronically. For detailed guidance, please refer to the

Project Handbook for your course.

SECTION 1 – STUDENT AND COURSE INFORMATION

MSc DETAILS AND DEADLINES (deadlines to be communicated by Course Director)

Academic Year 2009-10

MSc course (and stream, where applicable) TMIH

Deadline for Supervisor approval Friday 28th May 2010

Deadline for Course Director approval Friday 28th May 2010

Deadline for submission to Ethics Committee Friday 30 April 2010

Target for approved form to be passed to TSO Friday 28th May 2010

STUDENT, SUPERVISOR AND TUTOR DETAILS (to be completed by student)

Full name of student

Student email address

Year of study (part-time students

only)

First Year Second Year

Supervisor name

Professor Dianna Lockwood

Supervisor email address [email protected]

Supervisor status (at time of this

version of the form being completed)

Confirmed Provisional Still to be

identified

Name of personal tutor (where

Supervisor is still to be identified)

SECTION 2 – APPROVAL AND SUBMISSION STATUS

*Students please note: It is a requirement of your LSHTM degree that you obtain all

required approvals before beginning your project work. To comply with legal requirements,

your Supervisor and Course Director must specifically give Risk Assessment approval. Ethical

approval must also be obtained if required (answers in Section 5 will help determine if so).

STUDENT DECLARATION (to be completed for all projects)

I agree to conduct my project on the basis set out in this form, and to

consult staff (initially, my Supervisor) if making any subsequent changes –

especially any that would affect the information given with respect to

ethics approval.

I agree to comply with the relevant safety requirements, and will submit a

separate request for LSHTM travel insurance where relevant.

*Where seeking ethical approval for a study involving human subjects, please also attach

41 of 52

copies of any information sheets, consent forms, and other relevant documents.

Date of declaration 30/04/10

*Further note: when submitting your final project report at the end of the summer, you

should also include a copy of your approved CARE form (which will be seen by the project

markers); but to preserve anonymity, the page above – with your name – should be omitted.

42 of 52

STAFF APPROVAL

*Staff please note: Sections 3 and 4 of the form should be completed by the student before

you are asked to sign. If you tick ‘no’ to any of the ‘Yes/No’ questions below, or disagree with

any of the statements given, or have any other concerns, then you should not give approval –

instead, please contact the student immediately to inform them of your concerns and discuss

changes which they may need to make before you may be willing to give approval.

*Supervisors and Course Directors should also be aware that in the exceptional case of a

request to undertake a project in a country or region to which the Foreign & Commonwealth

Office advise against travel, the student would need to fill out a separate form which will then

need further School-level approval by the Safety Manager and Secretary & Registrar.

SUPERVISOR’S APPROVAL (required for all projects – this approval should be given first)

I agree that Section 3 of this form is a reasonable summary of the

proposed project.

Yes No

I agree that responses in Section 4 of this form address the main

risks connected with a project of this nature.

Yes No

Name of Supervisor (if not yet identified, personal

tutor or Course Director should approve)

Professor Dianna Lockwood

Date of approval 4/5/10

COURSE DIRECTOR’S APPROVAL (required for all projects – should follow Supervisor approval)

I agree that the academic content of the proposed project, set out at

Section 3 of this form, is suitable for this MSc.

Yes No

I agree that responses in Section 4 of this form address the main

risks connected with a project of this nature.

Yes No

Name of Course Director (or nominee) Robin Bailey


DEPARTMENTAL SAFETY SUPERVISOR’S APPROVAL (only required if project involves working

with pathogenic organisms, human blood or radiochemicals – should follow Supervisor approval)

I agree that the proposed project, as set out in this form and

particularly Section 4, may proceed.

Yes No

Name of Departmental Safety Supervisor (or

nominee)

Michael Smith


ETHICAL APPROVAL (required for all projects involving human subjects or human data, except for

public domain data that cannot enable the identification of living people – NB that Supervisor approval must have been received before the application is submitted to the Ethics Committee)

Date application received 4/6/10

Ethics Committee application number assigned 009/438

On behalf of the Ethics Committee, I approve the project

proposal set out on this form.

Yes No

Name of Ethics Committee scrutineer Paula Elliott


43 of 52

SECTION 3 – APPLICATION FOR ACADEMIC APPROVAL

*All students should complete all sub-sections (3.1, 3.2 and 3.3); if particular questions

are not applicable to you then please write ‘N/A’.

3.1 PROJECT OUTLINE (should not normally exceed 750 words total)

Proposed project title: (should not normally exceed 20 words)

To undertake a literature search looking at long term follow up and out comes of Leprosy

affected patients who have undergone reconstructive hand surgery for nerve paralysis in

the upper limb. Combined with this I will undertake an audit of hand surgery occurring in

Leprosy affected patients in Anandaban Hospital Nepal. From this work I will put

together a project proposal for a follow up study of reconstructive plastic surgery in

patients with Leprosy in Nepal and their long term out comes.

Proposed project type:

*See course-specific section of Project Handbook for details of project types permitted

for each MSc. Be aware that restrictions may apply for individual courses.

A paper describing a piece of research work carried out by the student during the course including a comprehensive and original review of the literature on the relevant subject and culminating in a proposal for a longer term project.

Proposed project length:

*For almost all students, this will be ‘Standard’. Long and extended projects are only

available for certain ITD courses; they have a different schedule and allow a slightly

greater word count.

Standard Long Extended

Background: (about 200 words)

*Indicate why this topic is of interest or relevance.

*If the project involves work with a specific organisation please give details.

*Please give any other details specifically relevant for consideration by the Ethics

Committee, e.g. related to purpose.

I intend to conduct a systematic review of the current literature on long term outcomes

of Leprosy patients having undergone reconstructive hand surgery for upper limb nerve

palsies. Through this I will high light the need for further research to be conducted in

this area. I will combine with this an audit of the presentation; operations performed and

follow up of patients having undergone reconstructive hand surgery second to Leprosy at

Anandaban Hospital Nepal over a five-year period. This will generate new data on

surgical practice and need with in this region. I will then put forward a proposal for a

larger long term follow up study on outcomes of patients who have undergone

reconstructive hand surgery in Nepal. This will add to the data set on functional status

and resulting disability experienced by these patients in the years post operatively.

Hypothesis: (about 30 words, where applicable)

Overall aim of project: (about 30 words)

To identify the operable upper limb nerve palsies that are presenting to a Leprosy

hospital in Nepal and are undergoing surgery, and to review the literature on out comes

and follow up of post operative reconstructive hand surgery patients with Leprosy. From

this work I intend to propose a longer term follow up study to look at function and

disability in post surgical Leprosy patients in Nepal.

Specific objectives of project: (about 70 words)

To investigate the current literature on the functional out comes disability and follow up

44 of 52

of leprosy affected patients who have undergo reconstructive surgery in the hand to

correct upper limb nerve palsies. Using patient notes I will then conduct an audit on the

current presentation and operations performed for hand palsies second to Leprosy at a

Leprosy Hospital in Nepal in an attempt to identify the type of operations being

performed and the surgical need in this resource poor setting.

I then intend on proposing a long term follow up study of patients in Nepal who undergo

surgery and their functional out comes and disability at 5 years. My intention is to

provide evidence as to where the allocation of scarce plastic surgical resources may be

best directed in Nepal’s Leprosy care facilities.

Proposed methods: (about 200 words)

*Please summarise methods, and include any relevant details for consideration by

the Ethics Committee such as numbers of participants and procedures to be

performed.

The systematic literature review shall be conducted at the LSHTM and from my home

(London). I will use the library and on line data resources to comprehensively cover all

published and other resources (such as gray literature) to the best of my ability ensuring

an encompassing over view of the subject.

The audit on presentation and operation performed on patients with upper limb nerve

palsies second to Leprosy will be conducted at Anandaban Leprosy Hospital Nepal. All

data collected will be anonymised and collected on a secure encrypted data spread

sheet. Any demographic or data that could identify a patient will be remove from the

data set. I will ensure that I have received ethics approval from the LSHTM and from the

Nepal ethics committee before any data collection occurs. The number of patient notes

used will vary dependent on the number of operations performed over the last five years

but I estimate of about 250 notes will be used. I will endeavour to ensure that my

activates are as a minimal a disruption to the notes department at Anandaban hospital

as possible. The writing up and further project proposal aspect of my summer project

will occur back in the UK. When proposing my further research I will take in to

consideration the constrains sensitivities and ethics that are appropriate for conducting

research in Nepal. I aim to propose a project that will be of scientific value not only to

Anandaban Hospital but to all those providing surgical care to Leprosy patients in

resource poor settings.

References: (max 150 words)

*List any key references which will shape the project, including for methods to be used.

It should not normally be necessary to quote more than 5 references.

The role of surgery in leprosy rehabilitation - a general overview.

Antia N.H. International Journal of Leprosy. 47(2 Sup.)(pp X 316), 1979.

Incidence of acute nerve function impairment and reactions in Leprosy: a

prospective cohort analysis after 5 years of follow up. Richards J. H,

Nicholls P. G, Croft R. P, Withington S. G, Smith W. C. S. International Journal of

Epidemiology 2004;33:337-343.

Reconstructive surgery in upper limbs in Leprosy. Roy C, Nath N. C, Saha S.

R. Journal of the Indian Medical Association. 102(12):702-3, 2004 Dec.

Leprosy Britton J. W, Lockwood D. N. J. The Lancet 2004;363:1209-19.

Leprosy. A disease of the Schwann cell. Leprosy In India. 54(4)(pp 599-604),

1982. Date of Publication: 1982.

Prior work: (only where relevant; max 100 words)

*Indicate any previous work you have done related to this project topic, including

student work, professional work, or publications.

I have spent a week assisting a visiting consultant plastic surgeon at Anandaban Hospital

Nepal. I am familiar with the staff and hospital setting there all though I have not

conducted any research at this site before.

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3.2 FEASIBILITY (about 100 words total – but can write more or write less if

appropriate)

What could cause this project to fail, i.e. prevent you from achieving your

objectives?

*Please indicate any aspects of your proposed approach which could potentially

experience difficulties, e.g. delays with permissions, data collection or storage problems,

lack of sufficient comparable information, etc. You may also wish to mention any wider

matters which could affect your project, e.g. civil unrest, natural disasters, transport

availability.

Difficulties in gaining ethical consent.

Political difficulties in Nepal preventing travel to the country.

Aeronautical restrictions (such as volcanic ash) preventing travel.

Difficulties in travel with in the country due to strikes, road conditions, weather

(monsoon season) etc.

Difficulties in identifying adequate patient notes for audit purposes.

Language difficulties and problems with translation.

What alternative plans do you have in case you encounter any of the potential

problems you have identified?

If difficulties that are insurmountable are met then a more extensive and broad

systematic literature search on surgery in Leprosy affected patients will be conducted.

3.3 INTELLECTUAL PROPERTY, COPYRIGHT AND OTHER PERMISSIONS

*Please also see Section 5.2 regarding any specific data rights limitations arising from

local ethical or research governance requirements

If you expect to use existing data, how will you obtain it and what permissions

will be required?

N/A

Having considered whether intellectual property rights (IPR) or copyright

issues may affect your project, will any specific agreements be required?

*Please tick all boxes that apply, and attach copies of any forms/agreements (even if in

draft).

No specific IPR, Copyright or permissions issues should apply to this project (student

retains Copyright and related IPR by default, in line with LSHTM registration

declaration)

IPR to be retained by LSHTM (specific LSHTM form to be completed)

Copyright to be transferred to LSHTM (specific LSHTM form to be completed)

IPR, Copyright or other agreements/permissions required with external

parties/organisations

Please give any further relevant details about IPR, copyright or other

permissions.

SECTION 4 – APPLICATION FOR RISK ASSESSMENT APPROVAL

*All students should answer all questions in sub-section 4.1; this will make clear which

of the following sub-sections you need to complete.

Ensuring safety during project work is the responsibility of each individual

46 of 52

student, and not of LSHTM or LSHTM staff. *Please see the Project Handbook for

further guidance.

4.1 TYPE OF RISK (to be completed by all students)

Where will the project be carried out? (please tick all that apply)

*Note that work away from LSHTM or outside the UK means any form of work for your

project, not just primary data collection. Some courses may have specific restrictions on

this.

All work will take place either at LSHTM, in libraries in the UK, or at my

personal residence in the UK. [If so, you do not need to complete either section 4.2

or section 4.3]

Some work will take place in the UK that is away from LSHTM sites in

London, is non-Library-based, and is not at my personal residence. [If so, section

4.2 on ‘Work away from LSHTM’ must be completed]

Some work will take place at my personal residence outside the UK [If so,

section 4.3 on ‘Work outside the UK’ must be completed]

Some work will take place outside the UK that is not at my personal

residence [If so, both sections 4.2 and 4.3 on ‘Work away from LSHTM’ and ‘Work

outside the UK’ must be completed]

Will the project involve working with or handling any of the following

materials?

Pathogenic organisms Yes No

Human blood Yes No

Radiochemicals Yes No

[If ‘Yes’ to any of the above, Sections 4.4 and 4.5 must be completed]

Are any other potentially hazardous activities likely to be carried out during the

project?

Yes No

[If ‘Yes’, Section 4.5 must be completed]

Do any special requirements (e.g. disability-related issues) or other concerns

need to be taken into account for either you as a student, study participants or

colleagues?

Yes No

[If ‘Yes’, Section 4.6 must be completed]

4.2 WORK AWAY FROM LSHTM (to be completed if any work will be done away from

LSHTM, other than at your home or at libraries elsewhere in the UK)

Will the project be based in an established hospital, college,

research institute, NGO headquarters, field station or other

institutional site? If ‘Yes’, please give the name and location of the

site(s); describe approximately what proportions of your project will be

spent there; and state name and role of person who has confirmed

willingness to support you at each site (indicating extent of

correspondence, especially what they have confirmed in writing).

Yes

No

Anandaban Leprosy Hospital, PO Box 151, Kathmandu, Nepal. Between 2-4 weeks will

be spent at the hospital and it will be the primary site for data collection. Dr Indra Napit/

Deanna Hagge have been contacted via email and I have met in person on a previous

visit to Nepal.

Will you have an ‘external supervisor’, co-supervisor or other Yes

47 of 52

main advisor, or be working with any specific organisation(s),

during your work away from LSHTM? If ‘Yes’, please indicate the

name, role, contact details, and level of support that any such external

advisors are expected to provide, and give details about any

organisations you will be working with.

No

Advisory and support role; Mr D Sammut (Consultant Plastic Surgeon specialist in Hand

surgery) The Hand Clinic Oakley Green Windsor SL4 4LHb England. Tel: 01753832109. [email protected]

Will the project involve personal visits, interviews or interactions

with people in their homes, workplaces, community settings or

similar? If ‘Yes’, please give details, including approximately what

proportion of your project this will involve.

Yes

No

Will the project involve lone/isolated work or significant travel? If

‘Yes’, please give details, including approximately what proportion of your

project this will involve, and state how you can be contacted while

working or travelling.

Yes

No

International flight London to Nepal. Accompanied travel to Anandaban Hospital (aprox 1

hr car ride). Can be reached by email and by phone during this time.

What arrangements are proposed for contact with your main supervisor while

you are away from LSHTM? Indicate expected ease and frequency of contact, and

communication methods to be used.

Email and phone which can be achieved with relative ease.

Please tick to

confirm:

I have read the LSHTM Code of Practice on off-site

work.

4.3 WORK OUTSIDE THE UK (to be completed if any work will be done outside the UK)

What form of project work will be undertaken outside the UK? (please tick all that

apply)

Work at my family home or personal residence only

Work at an established hospital, college, research institute, NGO

headquarters, field station or other institutional site

Work away from my personal residence or an established site

*Note that for either the second or third options, you should also have completed

Section 4.2.

Name the country/countries and region(s) in which work will be undertaken:

Country or countries: Nepal Region(s) : Kathmandu Valley

Do the Foreign & Commonwealth Office’s (FCO) Travel Advice

Notices (www.fco.gov.uk/en/travelling-and-living-overseas/travel-

advice-by-country/) advise against travel to the regions(s), country

or countries involved?

*Note that if ‘Yes’, the School will not normally permit such travel for project work. In exceptional circumstances only, requests may be considered by the Safety Committee and require approval by the Safety Manager and Secretary & Registrar.

Yes

No

Please tick to confirm: I understand that LSHTM travel insurance is

required for any international travel as part of my

project.

mailto:[email protected]

http://www.fco.gov.uk/en/travelling-and-living-overseas/travel-advice-by-country/

http://www.fco.gov.uk/en/travelling-and-living-overseas/travel-advice-by-country/

48 of 52

*Travel insurance can be applied for using a separate form.

4.4 WORK WITH HAZARDOUS SUBSTANCES (to be completed if the project involves

any work with pathogenic organisms, human blood or radiochemicals – NB that this will

require approval by the Departmental Safety Supervisor)

Name the organism or organisms to be used:

N/A

Identify all potential routes of infection:

N/A

Name the radiochemical or radiochemicals to be used:

N/A

List laboratories where work with pathogens or radioisotopes will be carried

out:

N/A

List disinfectants to be used, and describe arrangements for disposal of used

material:

N/A

Will or might Health Surveillance be required for you or any staff

working with you? If ‘Yes’, please give details.

Yes

No

N/A

4.5 PRECAUTIONS AGAINST HAZARDS (to be completed if any potentially hazardous

activities are likely to be carried out during the project. Refer to Project Handbook and

School safety documentation for further information. Departmental Safety Supervisor’s

approval should be obtained where felt appropriate by project Supervisor.)

Indicate any procedures, activities or aspects of the proposed project which

may entail hazards (including work with hazardous substances as per Section

4.4, or anything else relevant). Please set distinct hazards out separately, in a

numbered list.

N/A

Indicate the precautions you will take to prevent or mitigate such potential

hazards. Please number these to refer to the specific hazards identified in the preceding

question.

N/A

4.6 SPECIAL REQUIREMENTS (to be completed if the project involves any special

requirements, e.g. disability-related issues, or other concerns that need to be taken into

account for either you as a student, study participants or colleagues)

What special requirements or concerns need to be taken into account?

N/A

Do these need to be considered in planning arrangements?

If ‘Yes’, please give details.

Yes

No

N/A

Do these impact on supervision arrangements? Yes

No

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N/A

Does the project location need to be considered in relation to

these?


Yes

No

N/A

Do arrangements for access to specialist medical treatment need

to be considered?


Yes

No

N/A

SECTION 5 – APPLICATION FOR ETHICS APPROVAL

*All students should answer all questions in sub-sections 5.1 and 5.2. Answers to

5.1 will make clear whether approval by the LSHTM Ethics Committee is necessary, and

which later sub-sections you may need to complete. Section 5.2 covers any external

approvals required.

5.1 SCOPE OF STUDY (to be completed by all students)

*Before completing this part of the form, please read the Ethics Approval Policy &

Procedure plus guidance notes at http://intra.lshtm.ac.uk/reference/ethicsstuds.html .

This describes what to do next if formal LSHTM ethics approval is required. NB that

supervisor approval must be obtained before an application is submitted to the Ethics

Committee.

Which of the following applies to your project? (please tick one option only)

*Note – the term ‘human data’ includes any documentary data, datasets or biological

samples.

Project does not involve any human subjects or any human data. [If so, formal

LSHTM ethics approval is not required and you do not need to complete Sections 5.3 or

5.4]

Project involves human data, but all this human data is fully in the public

domain. [If so, formal LSHTM ethics approval is not required and you do not need to

complete Sections 5.3 or 5.4]

*Public domain human data must be: available to any member of the public without

special permission; to which access is not restricted in any way; and which does not

enable the identification of living people, either directly or by linking to other data.

Project involves some non-public-domain human data, all of which was

previously collected in another study or studies. [If so, formal LSHTM ethics

approval is required and Section 5.3 must be completed]

Project involves some additional collection of data, further to an ongoing or

previously completed study or studies. [If so, formal LSHTM ethics approval is

required and Section 5.4 must be completed]

Project is a completely new study which will involve human subjects or

human data. [If so, formal LSHTM ethics approval is required and Section 5.4 must be

completed]

5.2 LOCAL ETHICAL APPROVAL OR RESEARCH GOVERNANCE APPROVAL (to be

completed by all students)

* As well as approval from the LSHTM Ethics Committee, projects may require specific

http://intra.lshtm.ac.uk/reference/ethicsstuds.html

50 of 52

approval from other involved or responsible bodies. For example, in the UK you may

need specific authorisation to work in an NHS facility, or to work with vulnerable groups

such as patients or children. Outside the UK a wide range of requirements may apply

e.g. from local or national Ethics Committees, government departments etc. Students

must investigate all potential local approval required for your project work.

Failure to check or gain any necessary external approval may invalidate LSHTM

approval.

Is local approval required for the work being done (whether this

approval is still to be obtained, or has already been granted)?

*This should include any forms of ethical approval, research governance

approval or other specific permissions that may apply.

Yes

No

If ‘Yes’, give details of local approval to be obtained (this must be in place

before commencing fieldwork) or which has already been granted.

*Please name all bodies whose approval is required, or indicate where work is expected

to take place using permissions already granted for a ‘parent’ project. Where approval

has already been granted, quote approval reference numbers and if possible give web

links to documents.

If ‘No’, explain why formal local approval is not required, and describe any less

formal permissions, invitations or support you are being given for this work.

*If you will be working away from LSHTM with human subjects or human data, but

cannot identify a local Ethics Committee or believe that no formal approval is required,

then please give details and explain what you have done to check this. In such cases, if

you do not have formal approval you should always demonstrate appropriate local

support, such as correspondence with local government officials or an involved Non-

Governmental Organisation.

Nepal research council ethics approval.

For data to be used or collected in the project, will any specific

data rights permissions be required or usage limitations apply?

Yes

No

5.3 PROJECTS USING ONLY PREVIOUSLY-COLLECTED HUMAN DATA (to be

completed if project involves non-public-domain human data, datasets or biological

samples previously collected in another study or studies; if collecting any new data,

complete Section 5.4 instead)

*Further guidance is given at http://intra.lshtm.ac.uk/reference/ethicsstuds.html

Summary of purpose and methods of the original study or studies: (max 100

words)

N/A

Give details of all approvals under which the original study or studies took

place:

*Please quote names of Ethics Committees and approval reference numbers (required if

previous approval was from LSHTM); if possible give web link to original study

application.

N/A

Proposed study: Ensure that the project outline given in Section 3.1 states the

purpose, methods and procedures of the new work to be done in your project,

and describes how this builds on the previous study or studies (for which

participants will already have been recruited, data or samples collected, and

procedures performed). Do not reproduce here.


51 of 52

Will your analyses be for purposes not covered by the original

application detailed above? If ‘Yes’, indicate how you will obtain (i)

permission to use the data from the principal investigator responsible for

each original study; and (ii) retrospective consent, where appropriate,

from the participants in each original study.

Yes

No

N/A

Does the project involve analysis of documentary information

and/or data already collected from or about human subjects? If

‘Yes’, specify analyses briefly.

Yes

No

N/A

Does the project involve laboratory analysis of human biological

samples already collected, or new or additional analysis of stored

samples? If ‘Yes’, specify the laboratory analyses or tests to be

performed.

Yes

No

N/A

Specify how confidentiality will be maintained. When small numbers are

involved, indicate how possible identification of individuals will be avoided.

N/A

5.4 PROJECTS COLLECTING ANY NEW HUMAN DATA (to be completed if project

involves collection of human data, datasets or human biological samples – either as a

completely new study, or collecting additional data further to an ongoing or previously

completed study)

*Further guidance is given at http://intra.lshtm.ac.uk/reference/ethicsstuds.html

Proposed study: Ensure that the project outline given in Section 3.1 contains

sufficient detail (inc. purpose, methods, procedures for both new data collection

and any work building on previous studies), so as to allow the Ethics Committee

to make an informed decision without reference to other documents. Do not

reproduce here.

Is your project a randomised trial? Yes

No

Will any human biological samples be collected? If ‘Yes’, specify

details.

Yes

No

Will any human biological material be stored at LSHTM for more

than 24 hours? If ‘Yes’, specify which samples and how they will be

stored.

*Further guidance is given at

http://intra.lshtm.ac.uk/safety/Safety%20manual-3-HTA.pdf

Yes

No

Specify the number - with scientific justification for sample size – age, gender,

source and method of recruiting subjects for the study.

Audit of approximately 250 patients medical notes (last 5 years of operations notes) to

form an anonymised data set for analysis.

State the location and likely duration of new or additional human data

collection, and the extent to which this will be carried out by you alone, or in

collaboration with others, or by others.


http://intra.lshtm.ac.uk/safety/Safety%20manual-3-HTA.pdf

52 of 52

Location of data collection is Anandaban Hospital Nepal. Data collection will take

approximately 2-4 weeks conducted by me alone with assistance from the records

department at the hospital.

State the potential distress, discomfort or hazards, and their likelihood, to

which research subjects may be exposed (these may include physical,

biological and/or psychological hazards). What precautions are being taken to

control and modify these hazards?

Medical notes will be used and data anonymised to ensure that no distress could occur to

patients whose notes are used in the study.

Specify how confidentiality will be maintained. When small numbers are

involved, indicate how possible identification of individuals will be avoided.

The numbers I am planning to collect will help maintain confidentiality I will also only be

collecting minimal demographics such as age gender type of leprosy, presence and type of

nerve palsy, and operation conducted. The data will be stored in a secure encrypted data

base and any specifics that may identify a patient will be omitted from the audit to ensure

confidentiality.

State the manner in which consent will be obtained from subjects and supply

copies of the information sheet and consent form.

Written consent is normally required. Where not possible, explain why and confirm

that a record of those giving verbal consent will be kept.

Where appropriate, please state if and how the information and consent form will be

translated into local language(s).

Consent from patients not required as collecting data for audit purpose.

As well as collecting new data, will your project also make use of

any human data or biological samples collected in a previous study

or studies? If ‘Yes’, summarise the purpose and methods of the original

study or studies – for which participants will already have been recruited,

data or samples collected, and procedures performed. (max 100 words)

Yes

No