PPH for Hemorrhoids: Con Sonia L. Ramamoorthy, M.D.1 and Julio Garcia-Aguilar, M.D., Ph.D.1

ABSTRACT

Pain and prolonged postoperative recovery following excisional hemorrhoidectomy have motivated surgeons to search for alternative methods of treating patients with symptomatic hemorrhoidal disease. Stapled hemorrhoidectomy is a relatively new procedure to treat patients suffering from grade 2 to 4 hemorrhoids. It is reported to have less postoperative pain and shorter recovery time than traditional interventions. However, at present there is minimal evidence to support its use as first-line therapy, and long-term efficacy and safety data are lacking. KEYWORDS: Stapled hemorrhoidectomy, procedure for prolapsing hemorrhoids,

Longo technique

Objectives: Upon completion of this manuscript, the reader should understand the current controversy surrounding the use of the stapled technique and the limitations of the current data and be able to draw comparisons to standard approaches.

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istorically, patients suffering from grade 2 to 4 prolapsing hemorrhoids who failed medical treatment were treated by rubber band ligation (RBL) or excisional hemorrhoidectomy. However, the limitations of treating patients with large or circumferential hemorrhoids with RBL, and the pain and lengthy recovery following excisional hemorrhoidectomy, have prompted surgeons to search for other methods of treatment. Unfortunately, none of the other interventional techniques that have been tried have proven to be superior to RBL or excisional hemorrhoidectomy. Recently, stapled hemorrhoidectomy (procedure for prolapsing hemorrhoids, PPH) has been heralded as a virtual panacea for many symptomatic patients. Stapled hemorrhoidectomy has been associated with less morbidity, faster recovery, and improved quality of life when compared with excisional hemorrhoidectomy. The stapled technique as a first- or second-line treatment has not been supported by well-designed trials that allow for accurate comparisons to conventional surgical and non-surgical approaches. Moreover, the early

enthusiasm for this technique has led to unclear indications for treatment, inadequate training in the use of equipment, and complications from lack of experience. Stapled hemorrhoidectomy is an outpatient procedure best described as an anorectopexy. Redundant rectal mucosa is excised and reapproximated back into the rectum by a circumferential stapling device. The tissue “pexy” is performed proximal to the hemorrhoidal cushions, 4 to 5 cm above the dentate line, and interrupts blood flow through the upper and middle hemorrhoidal vessels. External hemorrhoids and thrombosis are not addressed by the procedure but may be dealt with at the same time. Since its introduction, the stapled hemorrhoidectomy has generated a surprising number of studies. Unfortunately, most of the published literature regarding this technique consists of small trials and retrospective analysis. Many of these report encouraging results but lack sufficient statistical power and long-term followup. A recent meta-analysis by Sutherland et al was unable

Controversies in Colon and Rectal Surgery; Editor in Chief, David E. Beck, M.D.; Guest Editor, Thomas E. Read, M.D. Clinics in Colon and Rectal Surgery, volume 16, number 4, 2003. Address for correspondence and reprint requests: Sonia L. Ramamoorthy, M.D., Section of Colon and Rectal Surgery, University of California, San Francisco, UCSF Medical Center, 505 Parnassus Ave., M-887, Box 0144, San Francisco, CA 94143. E-mail: [email protected]. 1Section of Colon and Rectal Surgery, University of California, San Francisco, UCSF Medical Center, San Francisco, California. Copyright © 2003 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA. Tel: +1(212) 584-4662. 1531-0043,p;2003,16,04,255,258,ftx,en;ccrs00147x.

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to demonstrate the superiority of the stapled technique due to the limited number of randomized control trials with adequate samples sizes and sufficient follow-up.1 Furthermore, patient symptoms, grade of hemorrhoid disease, and other patient characteristics vary from study to study, making global comparisons difficult. Data from European and Asian studies regarding length of stay following hemorrhoidectomy are difficult to interpret, as health systems in these regions of the world may allow for prolonged hospitalization or may have financial incentive to keep patients in the hospital longer. Despite this lack of convincing evidence, stapled hemorrhoidectomy remains a popular technique among surgeons because of the perceived advantages of reduced postoperative pain and expedited recovery. Hemorrhoids are classified by location and degree and therefore can be present in various forms (internal, mixed, and so on) with variable symptoms. For example, a patient with grade 2 hemorrhoids can be very symptomatic, whereas someone with grade 3 disease may not have any symptoms at all. Therefore, a patient’s symptoms, severity of disease, lifestyle, comorbid conditions, and acuity play into the surgical decisionmaking process. One of the problems with the stapled technique is finding an appropriate indication for use. A consensus statement to address this specific issue was developed by an international panel of experts funded in part by industry.2 The indications listed include selected grade 2, grade 3, and 4 hemorrhoids or failure to alleviate hemorrhoid symptoms by other methods. While the statement provides guidance for indications, it fails to specifically address the issue of whether the stapled technique is an appropriate form of first-line therapy for symptomatic hemorrhoids at any stage of disease. This is an important issue both from a clinical and an economic standpoint. In the study by Arnaud et al, only 10% of patients with grade 2 to 4 disease were offered any other form of treatment prior to stapled hemorrhoidectomy.3 The consensus statement cites the need for multicenter, prospective, randomized, controlled trials, leaving one to question whether any consensus statement can be created without the data from such studies. Most patients who have hemorrhoid symptoms can be managed nonoperatively. Dietary modification and high fiber supplementation has a significant success rate in the management of patients with hemorrhoidal disease.4 As an initial approach, this form of therapy not only provides alleviation of symptoms in many patients, but is thought to prevent progression and recurrence of disease as well. In a study by Moesgaard et al, symptoms of bleeding and pain in hemorrhoid patients were reduced by fiber supplementation.5 More aggressive techniques to manage this group of patients are often unnecessary. When dietary modification, fiber supplementation, and change in bathroom habits fail to improve symptoms, or when patients complain of significant bleeding or pro-

lapse, rubber band ligation (RBL) is considered by many practitioners to be the next best treatment option. An inexpensive, clinic-based procedure that does not require anesthesia or preparation, RBL has been shown to have success rates as high as 70 to 90%.6,7 Savioz et al showed that two thirds of patients with grade 2 hemorrhoids have symptom resolution, and more than half of patients remained symptom-free 10 years after treatment with RBL.8 In a meta-analysis comparing different treatment modalities for symptomatic hemorrhoidal disease (grade 1 to 3), MacRae and McLeod found RBL to be the best treatment method, with the main outcomes being response to therapy, the need for further therapy, complications, and pain.9 The comparison of RBL with the stapled technique is perhaps the most meaningful evaluation, since both are designed to treat symptomatic prolapsing hemorrhoids without addressing an external component. In a recent study by Peng et al, 55 patients with grade 3 to 4 hemorrhoids were randomized to either RBL or the stapled technique.10 Although Peng’s study includes a small number of patients, the findings are nevertheless intriguing. Postprocedure pain was more common in the stapled group when patients were followed up at discharge, 2 weeks, 2 months, and 6 months. Immediate postoperative complications such as bleeding and urinary retention were also more common in the stapled group. The RBL group suffered no immediate postprocedure complications, whereas a small number of patients in the stapled group required readmission for bleeding, catheterization for urinary retention, and dilation for anal stenosis. With regard to long-term efficacy, at 6 months’ follow-up, the RBL group had a higher rate of recurrent symptoms, 36% versus 23% in the stapled group. Although the study was underpowered, it has provided preliminary data on which future studies can be based. There are no studies to compare the cost of RBL to that of the stapled technique. The cost of an operating room procedure and potential overnight admission render the stapled technique a less attractive option when compared with RBL as a form of first-line therapy for symptomatic hemorrhoids. Economic concerns and the data from Peng’s study suggest that patients with symptomatic hemorrhoids not responding to medical therapy should initially be approached by outpatient RBL. Patients who fail multiple attempts at RBL, have symptomatic internal and external hemorrhoids, or those with strangulated/gangrenous hemorrhoids are traditionally referred for excisional hemorrhoidectomy. The stapled technique does not address large external hemorrhoids and is contraindicated in cases of strangulated hemorrhoids.2 The multiple randomized control trials comparing the excisional and stapled techniques have focused on the treatment of prolapsing grade 2 to 4 hemorrhoids. The results of the prospective trials have predominantly shown the stapled hemorrhoidectomy to be

PPH FOR HEMORRHOIDS: CON/RAMAMOORTHY, GARCIA-AGUILAR

more effective at reducing pain and promoting early recovery.3,11,12 However, many of these studies fail to provide data on patient characteristics, for example, length of time and severity of symptoms and failure of conservative management (including RBL). Without specific data on indications for treatment, it becomes difficult to draw conclusions about the reported benefit of the technique. This point is critical as there are several therapeutic options available depending on symptoms and physical exam findings. The data on dietary modification and RBL demonstrate that resolution can be achieved by lesser means in many cases.4 In a study by Singer et al, only 63% of the patients were treated with diet modification and 16% by RBL prior to undergoing the stapled procedure.13 It is unclear why only 16% of the patients in this study were eligible for treatment with RBL. One possible explanation is circumferential hemorrhoid disease. The stapled and three-quadrant excisional techniques are best suited for patients with circumferential prolapsing hemorrhoids. In many of the published trials on PPH, it is unclear whether circumferential disease or single column disease is being treated. In our practice this is not as common as single-quadrant disease. A study by Hayssen et al found that the majority of patients with hemorrhoidal disease requiring excision could be managed effectively by focused treatment of the problematic columns.14 Only 2% of the 115 patients studied required further procedural intervention at 8-year follow-up. A circumferential anorectopexy in these cases would be overtreating the benign quadrants and medically unnecessary. The literature on complications after stapled hemorrhoidectomy is variable. Early studies have shown similar short-term complication rates for the stapled technique and excisional hemorrhoidectomy. Despite the reassuring results from these early studies, serious complications such as pelvic sepsis, rectal perforation, persistent pain, and anal sphincter dysfunction continue to be reported in the literature.15–18 Data on late complications with stapled hemorrhoidectomy, such as anal stenosis, fistula formation, incontinence, and chronic anal pain, are lacking. A recent paper from Italy with 4year follow-up showed the stapled technique to be at least as safe as open hemorrhoidectomy with the only reported long-term complication being recurrent prolapse in 4% of patients treated by the stapled technique.19 Five- and ten-year follow-up in a larger group of patients is required to determine the nature and severity of long-term complications associated with the technique. The stapled hemorrhoidectomy represents a new technique aimed at improving patient outcome from symptomatic hemorrhoidal disease. Despite the numerous studies comparing the stapled technique to traditional approaches, there is minimal evidence to support its use as a first-line treatment modality in patients with symptomatic hemorrhoids. Diet modification and RBL

remain the most clinically and economically sound treatment options with demonstrated long-term efficacy and minimal morbidity. For patients with mixed hemorrhoids, a large external component, or associated pathology, there are insufficient data to support the claim that the stapled technique provides superior outcomes to excisional hemorrhoidectomy. The two techniques are designed to treat different forms of hemorrhoid disease. The reduction in postoperative pain and the shortened recovery period seen with the stapled technique may in fact be valid, but we must question whether we are comparing apples and oranges. With the literature showing that only 5 to 10% of symptomatic hemorrhoid patients require surgical intervention, it becomes a concern when a new technique creates a reason to operate.20 Further studies, free of industry sponsorship to strengthen conclusions, aimed at clarifying the indications for treatment in light of the recent comparison with RBL, and evaluating endpoints such as economic impact, will help define the role of stapled hemorrhoidectomy in the future. REFERENCES 1. Sutherland LM, Burchard AK, Matsuda K, et al. A systematic review of stapled hemorrhoidectomy. Arch Surg 2002; 137:1395–1406 2. Corman ML, Gravie JF, Hager T, et al. Stapled haemorrhoidopexy: a consensus position paper by an international working party—indications, contra-indications and technique. J Colorectal Dis 2003;5:304–310 3. Arnaud J-P, Pessaux P, Huten N, et al. Treatment of hemorrhoids with circular stapler, a new alternative to conventional methods: a prospective study of 140 patients. J Am Coll Surg 2001;193:161–165 4. Larach S, Cataldo TE, Beck DE. Nonoperative treatment of hemorrhoidal disease. In: Hicks TC, Beck DE, Opelka FG, Timmcke A, eds. Complications of Colon and Rectal Surgery. Baltimore, MD: Williams & Wilkins Publishers; 1997: 173–180 5. Moesgaard F, Nielsen ML, Hansen JB, Knudsen JT. High fiber reduces bleeding and pain in patients with hemorrhoids: a double-blind trial of Vi-siblin. Dis Colon Rectum 1982;25: 454 6. Sardinha TC, Corman ML. Hemorrhoids. Surg Clin N Am 2002;82:1–11 7. Komborozos VA, Skrekas GJ, Pissiotis CA. Rubber band ligation of symptomatic hemorrhoids: results of 500 cases. Dig Surg 2000;17:71–76 8. Savioz D, Roche B, Glauser T, Dobrinov A, Ludwig C, Marti MC. Rubber band ligation of hemorrhoids: relapse as a function of time. Int J Colorectal Dis 1998;13:154–156 9. MacRae HM, McLeod RS. Comparison of hemorrhoidal treatments: a meta-analysis. Can J Surg 1997;40:14–17 10. Peng BC, Jayne DG, Ho Y-H. Randomized trial of rubber band ligation vs. stapled hemorrhoidectomy for prolapsed piles. Dis Colon Rectum 2003;46:291–297 11. Ganio E, Altomare DF, Gabrielli F, Milito G, Canuti S. Prospective randomized multicentre trial comparing stapled with open haemorrhoidectomy. Br J Surg 2001;88: 669–674

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12. Wilson MS, Pope V, Doran HE, Fearn SJ, Brough WA. Objective comparison of stapled anopexy and open hemorrhoidectomy: a randomized, control trial. Dis Colon Rectum 2002;45:1437–1444 13. Singer MA, Cintron JR, Fleshman JW, et al. Early experience with stapled hemorrhoidectomy in the United States. Dis Colon Rectum 2002;45:360–367 14. Haysseen TK, Luchtefeld MA, Senagore AJ. Limited hemorrhoidectomy: results and long-term follow-up. Dis Colon Rectum 1999;42:909–914 15. Cheetham MJ, Mortensen NJ, Nystrom PO, Kamm MA, Phillips RK. Persistent pain and faecal urgency after stapled hemorrhoidectomy. Lancet 2000;356:730–733 16. Molloy RG, Kingsmore D. Life-threatening sepsis after stapled hemorrhoidectomy. Lancet 2000;355:810

17. Wong L-Y, Jiang J-K, Chang S-C, Lin JK. Rectal perforation: a life threatening complication of stapled hemorrhoidectomy: case report. Dis Colon Rectum 2003;46:116–117 18. Maw A, Eu K-W, Seow-Choen F, et al. Retroperitoneal sepsis complicating stapled hemorrhoidectomy: report of a case and review of the literature. Dis Colon Rectum 2002;45: 826–828 19. Racalbuto A, Alliotta I, Corsaro G, et al. Hemorrhoidal stapler prolapsectomy vs Milligan-Morgan hemorrhoidectomy: a long-term randomized trial. Int J Colorectal Dis 2003;45. Available at www.springlink.com. Accessed November 7, 2003 20. Bleday R, Pena JP, Rothenberger DA, Goldberg SM, Buls JG. Symptomatic hemorrhoids: current incidence and complications of operative therapy. Dis Colon Rectum 1992;35: 477–481