Culligan lecture

Robotic-Assisted Sacrocolpopexy

Patrick Culligan, MD, FACOG, FACS Director Atlantic Health Division of Urogynecology & Reconstructive Pelvic Surgery

Professor of Obstetrics Gynecology & Reproductive Science Mount Sinai School of Medicine

Key Components of Sacrocolpopexy

Sacrocolpopexy - History

 Sacral Colpopexy first described by Lane in 1962

  “Modern Version” described and refined by Addison in the 1980’s and 1990’s

 Dubbed the “main abdominal approach to prolapse surgery” in a systematic review article 2004 (Nygaard et al)

 That status solidified by a Cochrane review in 2005 (Maher et al)

“Tried & True”

 3 studies including greater than 200 patients & long-term follow-up:   Sullivan et al Dis Colon Rectum 2001.   Culligan et al. Am J Obstet Gynecol 2002.   Lindeque et al. S Afr Med J 2002.

Objective Anatomic Success Rates

85 – 100%

PATIENT SELECTION

My progression to robotic surgery

Does the patient have a uterus?

YES vaginal hysterectomy +

additional vaginal procedures

NO OPEN Sacrocolpopexy

2002 – switched to laparoscopic Sacrocolpopexy

2005 First daVinci Sacrocolpopexy

Now I frequently combine supracervical hyst and daVinci sacrocolpopexy

My Current Approach to Prolapse Surgery

What is the age and activity level of the patient?

“Younger” “Very Active”

“Older” “Less Active”

Laparoscopic Sacral Colpopexy (+ / - supracervical hyst)

Vaginal Mesh Placement

(probably no hysterectomy)

Severe Uterovaginal Prolapse (before and after robotic sacrocolpopexy)

45 year old

G2 P2 Athletic Very active (physically , sexually, etc…)

But.... Should this patient have a laparoscopic surgery?

78 year old

G5 P5

Significant co-morbidities

Not sexually active

Patient Positioning: # 3 arm comes in from patient’s LEFT

Patient’s Skin Directly Against “Megadyne” Gel

Pad

Shoulder Pads

Use side-docking when patient does NOT have a uterus

Port Placement - always the same...

Camera port - 12mm long bladed disposable Assistant port - 11 or 12 mm disposable (“Excel”) - size depends on whether you need to morcellate 4th arm port - WAY lateral and WAY high (a few cm lower than costal margin)

Instrumentation

Monopolar shears Maryland Bipolar SutureCut

Large Needle Driver

PK Dissector

Tenaculum ProGrasp

Comparison of Type-1 Polypropylene Mesh Products

Brand Name Pore Size (mm) Density (g/m2) Thickness (mm)

Alyte Y-mesh (CR Bard)

2.8 x x1.3 17.67 0.29

Restorelle Y (Coloplast)

1.8 x 1.8 18.96 0.31

IntePro Y-graft (AMS)

1.6 x 2.1 52.4 0.53

Gynemesh (Ethicon)

2.5 x 1.7 42.38 0.42

Polyform (Boston Scientific)

1.8 x 1.5 40.19 0.16

Novasilk (Coloplast)

1.5 x 1.7 18.66 0.25

SACROCOLPOPEXY steps of the procedure

First Steps

Supracervical Hysterectomy Why supracervical as opposed to TOTAL hyst...?? Probably decreases incidence of mesh erosion Cuts down or eliminates need for vaginal instrumentation

Anterior Dissection No Vaginal Instrumentation

Key Aspects: Have a specific goal in mind for each patient Create “fingers” by pushing most of tissue Use small amount of cautery when cutting these fingers

Posterior Dissection - No vaginal or rectal instrumentation

Key Points: Get in “the room” Have a specific “length goal” in mind Keep scope right on top of the action Maintain traction / counter-traction with each move

Posterior Dissection off to a bad start

Suggested Vaginal Instrumentation

  Lucite Dilators available from:   Progressive Medical Instruments, Louisville, KY   (800) 775-7644

If there is no uterus / cervix to grab...   Lucite Probe helps   Side-docking helps

If there is no uterus...   Try to leave “dome” of peritoneum intact at apex....

  Doing so may cut down mesh erosion risk

Long, Wide Briesky retractor helps with posterior dissection

Vasculature in Pre-Sacral Space

Middle Sacrals: Standard Hemostatic Measures Work Well

Lateral Sacral Plexus Be Afraid !

Sacral Dissection   Find “window of opportunity” at promontory   Dissect at least 1/2 way down paracolic gutter   Use minimal cautery   Usually no need to cauterize middle sacral vessels.

More Sacral Dissection

Sacral Bleeding

Sacral Bleeding

Similar case...better result

Mesh Placement

  Plan specific lengths of the mesh - i.e. have a goal in mind

  When using Y-Mesh, place a loose suture to fold anterior portion back out of your way

  Start with Posterior mesh

  In the Posterior compartment - It’s helpful to place sutures BETWEEN mesh and vaginal tissue – working your way from the perineum to the vaginal apex

Mesh Preparation

Posterior Mesh Placement

Anterior Mesh Placement

Peritoneal Closure: Step 1...Purse string

Sacral Suturing Key Aspects: You only need to expose enough of the ligament to allow suture placement Usually minimal cautery needed Usually no need to change from zero degree to 30 degree scope

Mesh Tensioning / Sacral Suturing

  When setting mesh tension at the sacrum:   No substitute for experienced hand   Either you or your assistant should place hand in vagina

during tensioning step   Goal - normal vaginal axis...not too tight...not too loose

Peritoneal Closure: Step 2 - paracolic gutter to sacrum (after sacral suturing)

Tricky Situations

  Prior Abdominoplasty

  Lung or Heart Disease

  Prior abdominal prolapse repair

  High BMI

  Very small women

OUR RESULTS

A Double-Blind Randomized Trial Comparing Porcine Dermis & Polypropylene Mesh for

Laparoscopic Sacrocolpopexy

OBJECTIVE To compare objective and subjective outcomes ≥ 12 months after laparoscopic sacrocolpopexy using organic or synthetic graft material

Methods

  Randomization on the day of surgery

  Surgery = Laparoscopic Sacrocolpopexy

  Approximately 80% were robotic

  All outcome measures collected by one research nurse

  PATIENTS & RESEARCH NURSE were blinded as to their graft material throughout the study period

Definitions of Cure

 “POP-Q Cure” (both criteria required)  All POP-Q points ≤ Stage 1  Point C -5 or better

 “Clinical Cure” (all 3 criteria required)  All POP-Q points < ZERO  Point C -5 or better  NO POP symptoms on PFDI / PFIQ

Sample Size Calculation Based on “POP-Q Cure”

(aka NIH definition)

Culligan et al 2004

  Randomized trial comparing cadaver fascia lata and synthetic mesh for OPEN sacrocolpopexy

 91% “cure” for mesh versus 68% “cure” for fascia lata (23% difference)

  With 57 patients per group we had 90% power to detect a difference of 23% (α = 0.05)

Enrollment period 2005 - 2008 Patients eligible for study

N = 184

Patients declined enrollment N = 64

Patients randomized to receive either organic or synthetic mesh N = 120

Organic Group N = 57

Synthetic Group N = 62

Lost to follow-up N = 0

Lost to follow-up N = 4

One patient converted to vaginal case on OR table (organic group)

Completing 12 month trial N = 57 (organic)

Completing 12 month trial N = 58 (synthetic)

12 Month “POP-Q Cure” (i.e. stage 0 or 1)

 Porcine Dermis 80.4%

 Synthetic Mesh 84.1%

p = 0.29

No Apical Failures

12 month “Clinical Cure”

 Porcine Dermis 84.2%

 Synthetic Mesh 84%

p = 0.96

No Apical Failures

Point C over time (pre-op to 12 months)

Point Aa over time (pre-op to 12 months)

Point Bp over time (pre-op to 12 months)

Single-Arm Cohort Study

  120 patients   Robotic Sacrocolpopexy using Restorelle Y-Mesh

Perioperative details (120 patients)

  Mean operative time 140 minutes (range 80-225)

  Defined as incision time to removal of trocars

  Mean EBL 49 mL (range 5 - 300 mL)

  No conversions to laparotomy

  One cystotomy ; No Rectal Injuries

  No Erosions

  No Transfusions

  All patients discharged on POD # 1

“POP-Q Cure” 89% (i.e. stage 0 or 1)

“Clinical Cure” 95%

No Apical Failures

Text

Cure Rates at 12 Months

Current Study (150 patients) Alyte Y-Mesh (CR Bard)

  Our

Interesting Situations

Patient with prior (failed) anterior vaginal mesh “kit”

“Gap Failure” (prior mesh kit)