488 From the Colorectal Section, Department of Surgery, Chang Gung Memorial Hospital at Linkou, Chang Gung University College of Medicine, Taoyuan, Taiwan. Received: Jan. 15, 2010; Accepted: Apr. 19, 2010 Correspondence to: Dr. Jinn-Shium Chen, Colorectal Section, Department of Surgery, Chang Gung Memorial Hospital at Linkou. 5, Fusing St., Gueishan Township, Taoyuan County 333, Taiwan (R.O.C.) Tel.: 886-3-3281200 ext. 2101; Fax: 886-3-3278355; E-mail: [email protected]H emorrhoids, cushions of vascular tissue in the anus, are one of the most common anal disor- ders. Etiologic factors for hemorrhoidal disease include constipation, diarrhea, prolonged straining, pregnancy, heredity, erect posture, increased intraab- dominal pressure with obstruction of venous return, aging, and internal sphincter abnormalities. Patients with hemorrhoids may complain of bright red bleed- ing from the rectum, anal pain, anal masses and pro- trusion, difficulties with perianal hygiene, and cos- metic deformities. Patients with symptomatic hemor- rhoids who have failed nonoperative treatments may require surgery. Conventional surgical hemor- rhoidectomy involves excision of the hemorrhoidal cushions and is the most effective treatment for hem- orrhoids. The Milligan-Morgan (open) and Ferguson (closed) hemorrhoidectomy are the most commonly used techniques worldwide. (1,2) However, there are a Review Article Current Status of Surgical Treatment for Hemorrhoids - Systematic Review and Meta-analysis Jinn-Shiun Chen, MD, FACS; Jeng-Fu You, MD Hemorrhoids are one of the most common anorectal disor- ders. Conventional hemorrhoidectomy is the most commonly practiced surgical technique. Stapled hemorrhoidectomy (pro- cedure for prolapse and hemorrhoids [PPH]) and Ligasure hemorrhoidectomy are newly developed methods for the surgi- cal management of hemorrhoids. The objective of this study was to compare the effectiveness and safety of these two novel techniques with that of conventional hemorrhoidectomy. From the MEDLINE data-base, we obtained papers published between January 2000 and September 2009 and retrospectively studied randomized, controlled clinical trials that compared PPH versus conventional hemorrhoidectomy or Ligasure hem- orrhoidectomy versus conventional hemorrhoidectomy. Both PPH and Ligasure hemorrhoidectomy were superior to conven- tional hemorrhoidectomy with regard to operation time, early postoperative pain, urinary retention, and time to return to normal activity. However, skin tags and recurrent prolapse occurred at higher rates in the PPH group. Although both new techniques have short-term benefits, especially in reducing extreme postoperative pain, more powerful clinical studies with long-term follow up and larger sample sizes should be con- ducted for further evaluation of outcomes. (Chang Gung Med J 2010;33:488-500) Key words:hemorrhoid, hemorrhoidectomy, stapled hemorrhoidectomy, PPH, Ligasure hemor- rhoidectomy Dr. Jinn-Shium Chen
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488
From the Colorectal Section, Department of Surgery, Chang Gung Memorial Hospital at Linkou, Chang Gung University College ofMedicine, Taoyuan, Taiwan.Received: Jan. 15, 2010; Accepted: Apr. 19, 2010Correspondence to: Dr. Jinn-Shium Chen, Colorectal Section, Department of Surgery, Chang Gung Memorial Hospital at Linkou. 5,Fusing St., Gueishan Township, Taoyuan County 333, Taiwan (R.O.C.) Tel.: 886-3-3281200 ext. 2101; Fax: 886-3-3278355; E-mail: [email protected]
Hemorrhoids, cushions of vascular tissue in theanus, are one of the most common anal disor-
ders. Etiologic factors for hemorrhoidal diseaseinclude constipation, diarrhea, prolonged straining,pregnancy, heredity, erect posture, increased intraab-dominal pressure with obstruction of venous return,aging, and internal sphincter abnormalities. Patientswith hemorrhoids may complain of bright red bleed-ing from the rectum, anal pain, anal masses and pro-
trusion, difficulties with perianal hygiene, and cos-metic deformities. Patients with symptomatic hemor-rhoids who have failed nonoperative treatments mayrequire surgery. Conventional surgical hemor-rhoidectomy involves excision of the hemorrhoidalcushions and is the most effective treatment for hem-orrhoids. The Milligan-Morgan (open) and Ferguson(closed) hemorrhoidectomy are the most commonlyused techniques worldwide.(1,2) However, there are a
Review Article
Current Status of Surgical Treatment for Hemorrhoids -Systematic Review and Meta-analysis
Jinn-Shiun Chen, MD, FACS; Jeng-Fu You, MD
Hemorrhoids are one of the most common anorectal disor-ders. Conventional hemorrhoidectomy is the most commonlypracticed surgical technique. Stapled hemorrhoidectomy (pro-cedure for prolapse and hemorrhoids [PPH]) and Ligasurehemorrhoidectomy are newly developed methods for the surgi-cal management of hemorrhoids. The objective of this studywas to compare the effectiveness and safety of these two noveltechniques with that of conventional hemorrhoidectomy. Fromthe MEDLINE data-base, we obtained papers publishedbetween January 2000 and September 2009 and retrospectivelystudied randomized, controlled clinical trials that comparedPPH versus conventional hemorrhoidectomy or Ligasure hem-orrhoidectomy versus conventional hemorrhoidectomy. BothPPH and Ligasure hemorrhoidectomy were superior to conven-tional hemorrhoidectomy with regard to operation time, earlypostoperative pain, urinary retention, and time to return to normal activity. However, skintags and recurrent prolapse occurred at higher rates in the PPH group. Although both newtechniques have short-term benefits, especially in reducing extreme postoperative pain, morepowerful clinical studies with long-term follow up and larger sample sizes should be con-ducted for further evaluation of outcomes. (Chang Gung Med J 2010;33:488-500)
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few common complications associated with conven-tional hemorrhoidectomies, such as urinary retention,postoperative bleeding, significant pain, anal steno-sis, and incontinence. Several modifications havebeen proposed to improve the postoperative out-come, and especially to reduce postoperative pain.
Stapled hemorrhoidectomy and Ligasure hem-orrhoidectomy
In 1998, to minimize postoperative discomfortfollowing conventional surgery, Longo proposed anew technique – stapled hemorrhoidectomy (alsoknown as procedure for prolapse and hemorrhoids[PPH]) – for treating hemorrhoids.(3) PPH is per-formed with a specially designed stapling device toexcise a complete ring of mucosa above the dentateline. The crucial characteristic of this procedure isthe absence of any perceived perianal wounds, whichtherefore should be less painful than conventionalhemorrhoidectomy.
In addition, the Ligasure vessel sealing system(Valleylab; Boulder, CO, U.S.A.) is another recentlyintroduced instrument consisting of a bipolar,(4) elec-trothermal, hemostatic device that ensures completecoagulation of vessels up to 7 mm in diameter withminimal surrounding thermal spread and limited tis-sue charring. This instrument could be an ideal toolfor hemorrhoidectomy because it enables effective,bloodless excision of hemorrhoids with minimal tis-sue trauma, and hence, possibly reduces postopera-tive pain and wound healing time.
The goal of this review was to compare theeffectiveness and safety of the two new techniqueswith that of conventional hemorrhoidectomy(Milligan-Morgan or Ferguson hemorrhoidectomy)based on a systematic review of prospective, ran-domized, controlled trials.
Search strategy from MEDLINEAll original, randomized, controlled, clinical tri-
als that compared stapled hemorrhoidectomy versusconventional hemorrhoidectomy or Ligasure hemor-rhoidectomy versus conventional hemorrhoidectomyfor the treatment of symptomatic hemorrhoids wereidentified. The analysis included papers publishedbetween January 2000 and September 2009 that wereidentified in a MEDLINE search. The search termswere as follows: hemorrhoid, hemorrhoidectomy,stapled hemorrhoidectomy, PPH, Ligasure hemor-
Inclusion criteria and data analysisOnly prospective, randomized, controlled trials
comparing PPH versus conventional hemorrhoidec-tomy, or Ligasure hemorrhoidectomy versus conven-tional hemorrhoidectomy were included in furthermeta-analysis. Comparative studies (nonrandomizedand retrospective), case series, and case reports werenot included. Studies published in languages otherthan English were excluded. All letters, abstracts,and personal communications were also excluded.
The present review focused on comparing PPHversus conventional hemorrhoidectomy and Ligasurehemorrhoidectomy versus conventional hemor-rhoidectomy with regards to operating time, postop-erative pain, length of hospital stay, time to return tonormal activity, residual external skin tags, and post-operative complications. Data were extracted inde-pendently from each study and differences were ana-lyzed. The meta-analysis and forest plots were con-ducted by the Review Manager 5 software tool of theCochrane Collaboration.
The systematic literature search identified 30randomized, controlled trials, 19 comparing PPHversus conventional hemorrhoidectomy and 11 com-paring Ligasure hemorrhoidectomy versus conven-tional hemorrhoidectomy.(5-34) The baseline character-istics of patients in the trials included in the meta-analysis are summarized in the Table 1. We focusedon the following outcomes: operation time, earlypostoperative pain, major postoperative hemorrhage,time to return to normal activity, postoperative analstenosis, postoperative incontinence, residual skintags, and recurrent prolapse.
Outcome – operation timeCompared with conventional hemorrhoidecto-
my, significantly shorter operation times were report-ed for PPH (Fig. 1A; p < 0.00001) and Ligasurehemorrhoidectomy (Fig. 1B; p < 0.00001).
Outcome – early postoperative painThe assessment of postoperative pain varied for
each study and was complicated by varying stages ofrecovery. A visual analog scale (0 indicating no painand 10 indicating severe pain) was the most com-monly used scoring method. The pain scores, either
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Table 1. Baseline Characteristics
Study Year Country Group No. of patients Mean age M/F
PPH vs. Conventional hemorrhoidectomyMehigan 2000 U.K. PPH 20 57.1 6/14
Wong 2008 Hong Kong PPH 21 53 13/8Milligan-Morgan 20 47 13/7
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at 24 hours after surgery or during the first bowelmovement, were collected for further analysis fromeach study. Significantly less postoperative pain wasexperienced by patients in the PPH (Fig. 2A; p <0.00001) and Ligasure groups (Fig. 2B; p < 0.0001)than those in the conventional groups.
Outcome – early postoperative urinary reten-tion
Both the PPH groups and Ligasure groups hadlower incidences of acute urinary retention aftersurgery than the conventional hemorrhoidectomygroups (Fig. 3).
Outcome – major postoperative hemorrhageMajor postoperative hemorrhage was defined as
bleeding requiring surgical intervention or warranti-ng hospital re-admission. The incidence of majorpostoperative hemorrhage was low and comparablein each treatment group as shown in Fig. 4A (PPHversus conventional hemorrhoidectomy, p = 0.15)and Fig. 4B (Ligasure hemorrhoidectomy versusconventional hemorrhoidectomy, p = 0.19).
Outcome – time to return to normal activityOn average, the time to return to normal activity
was shorter for the PPH groups than for the conven-tional hemorrhoidectomy groups (Fig. 5A; p <0.0001). Likewise, based on limited available docu-ments, the Ligasure groups resumed normal activi-ties faster than the conventional groups (Fig. 5B; p <0.0001).
There were no detectable differences betweenthe PPH and conventional groups, or between theLigasure and conventional groups in the incidence ofpostoperative anal stenosis and incontinence.
Outcome – residual skin tagsThe incidence of residual anal skin tags was sig-
nificantly greater in the PPH groups than that in theconventional groups (Fig. 6; test for overall effect: Z
= 2.61; p = 0.009). Documented data about residualskin tags from studies comparing Ligasure groupswith conventional groups were not available.
Outcome – recurrent prolapseOn average, there was better control of recurrent
prolapse in the conventional groups than PPH groups(Fig. 7; p < 0.0001), although there was statisticalheterogeneity between the studies (Chi = 10.66, p =0.30, I2 = 16%).
Fig. 1 Operation time (minutes): (A) PPH vs. conventional hemorrhoidectomy; (B) Ligasure vs. convention hemorrhoidectomy.
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ConclusionsIndications for surgical hemorrhoidectomy
include symptomatic hemorrhoids too extensive fornonoperative management, failure of medical treat-ment, and concomitant conditions, such as anal fis-sures or ulcers, that require surgery. Conventionalhemorrhoidectomy, including open and closed meth-ods, is accepted as the gold-standard for surgicaltreatment of hemorrhoids worldwide. However, themain drawback of conventional hemorrhoidectomyis extreme postoperative pain, especially when defe-cating. The complications of conventional hemor-
rhoidectomy are usually minor, including urinaryretention, bleeding, infection, stenosis, and inconti-nence.
In 1998, Longo introduced an alternativemethod, PPH, for the surgical treatment of hemor-rhoids using a circular stapling instrument whichremoves a ring of redundant rectal mucosa orexpanded internal hemorrhoids. The goal is to pullthe prolapsed hemorrhoid tissue back up into its nor-mal position within the anal canal as well as to dis-rupt the arterial inflow that traverses the excised seg-ment. In this method, skin tags and enlarged external
Fig. 2 Early postoperative pain: (A) PPH vs. conventional hemorrhoidectomy; (B) Ligasure vs. conventional hemorrhoidectomy.
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hemorrhoids are not removed, which undoubtedlycontributes to the reduced pain scores. This was con-firmed in this systematic review. The advantages ofPPH were a shorter operation time, less postopera-tive pain, less postoperative urinary retention, and aquicker return to normal activity. Although there areseveral short-term benefits, the long-term outcome isrelatively poor compared with that of conventionalhemorrhoidectomy, mainly considering the rate of
residual skin tags and recurrent prolapse.Accordingly, PPH should not be recommended forpatients who have symptomatic external hemor-rhoids.
Another interesting subject concerns whetherPPH is superior to other less invasive procedures,such as rubber band ligation of hemorrhoids. Rubberband ligation is a well-accepted procedure and issupposed to be safe and effective for symptomatic
PPH Conventional Odds Ratio Odds RatioStudy or subgroup Events Total Events Total Weight M-H, Fixed, 95% CI Year M-H, Fixed, 95% CI
Fig. 3 Early postoperative urinary retention: (A) PPH vs. conventional hemorrhoidectomy; (B) Ligasure vs. conventional hemor-rhoidectomy.
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internal hemorrhoids. However, hemorrhoids recur inapproximately one-third of patients who receiverubber band ligation which is much higher than thatfor PPH (8.7% in this review).(35-39)
PPH is technically demanding, and placement ofthe purse-string at the correct height and depth is
critical. Of particular note, serious complications fol-lowing PPH have been reported, including rectal per-foration, pelvic sepsis, rectovaginal fistula, intra-abdominal bleeding, and Fournier’s gangrene.(40-47)
Further surgery, either an exploratory laparotomy ordiverting stomy, was done in these cases. In addition,
PPH Conventional Odds Ratio Odds RatioStudy or subgroup Events Total Events Total Weight M-H, Fixed, 95% CI Year M-H, Fixed, 95% CI
Fig. 4 Major postoperative hemorrhage: (A) PPH vs. conventional hemorrhoidectomy; (B) Ligasure vs. conventional hemor-rhoidectomy.
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Cheetham et al. reported that 31% of patients experi-enced severe pain and fecal urgency,(48) which persist-ed for up to 15 months after PPH. This may resultfrom placing the purse-string suture too close to thedentate line with unintentional stapling of the sensi-tive anoderm and sphincters. An important caveat isthat misapplication of the purse-string suture, ateither an inadequate level (too high or too low) orinadequate depth (too deep or too superficial), mayresult in serious postoperative complications.
The Ligasure system is another recently intro-duced device which allows accurate application ofbipolar diathermy to vascular structures with mini-mal thermal spread and limited tissue charring.Technically, it is simple and easy to learn because thenew technique is a modified conventional hemor-
rhoidectomy which offers excellent hemostatic con-trol and avoids the need to ligate the pedicles.Improved hemostasis may also offer better visibilityand therefore a more accurate dissection. From thissystematic review, Ligasure hemorrhoidectomy issuperior to conventional hemorrhoidectomy in termsof operation time, postoperative pain, urinary reten-tion and time to return to normal activity. Althoughearly functional and symptomatic outcomes havebeen satisfactory, long-term follow-up of patientsfollowing Ligasure hemorrhoidectomy is necessary.
Although both new techniques, PPH andLigasure hemorrhoidectomy, provide short-term ben-efits, especially in reducing extreme postoperativepain, more clinical research should be conducted toevaluate long-term outcomes.
Fig. 5 Time to return to normal activity (days): (A) PPH vs. conventional hemorrhoidectomy; (B) Ligasure vs. conventional hem-orrhoidectomy.
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