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The quest for painless surgical treatment of hemorrhoids continues
EDITORIAL
The Quest for Painless Surgical Treatment of Hemorrhoids Continues Steven D Wexner, MD, FACS, FRCS, FRCS (Ed), Fort Lauderdale, FL
eral decades, each initially touted as the newest method to perform a hemorrhoidectomy without causing significant postoperative suffering from pain. This list includes cryotherapy11,12 and a plethora of instruments designed to remove the hemorrhoidal tissue while minimizing postoperative pain. The instruments that have been introduced to replace standard Milligan Morgan or Ferguson hemorrhoidectomy include the bipolar scissors, the diathermy instrument, the carbon dioxide and neodymium yag lasers, and, more recently, the monopolar coagulator (LigaSure, Valleylab, Boulder, CO),13 and the ultrasonic scalpel.14,15 The common denominator of each of these methods is that after the initial enthusiasm, detailed scientific scrutiny failed to confirm the preliminary claims, so widespread adoption never came to fruition. Examples include the cryotherapy trial performed by Smith and colleagues,11 and the experiences of Leff16 and subsequently Senagore and associates17 of laser hemorrhoidectomy. In fact, the latter study was a well-constructed large prospective randomized trial in which the only significant difference between the standard excisional technique and the laser was more prolonged wound healing in the laser group. The diathermy technique was originally advocated by John Alexander-Williams and coworkers18 at the General Hospital in Birmingham and described by Professor John Goligher of Leeds.19 Unlike some of the other techniques, two recent prospective randomized trials from the Singapore General Hospital have both supported that diathermy hemorrhoidectomy was associated with less pain than was scissors hemorrhoidectomy.20,21 But even these two trials failed to conclusively demonstrate a significant reduction in pain by all measures at all time points. Specifically, the study by Ibrahim and colleagues20 was unable to identify a significant difference in pain requirements during the first 24 hours after surgery, which is often the most critical point, because it is during that time period that severe pain may exacerbate urinary retention in male patients. Similarly, the Ho and associates study,21 found that although the use of post-
Even through the relatively few decades during which I have been educated and begun to practice colorectal surgery, I have seen numerous new techniques championed to reduce the pain associated with the surgical treatment of hemorrhoids. (See article in current issue by Arnaud and colleagues.)1 There is no reason to suppose that the many decades and, in fact, centuries before my participation did not include multiple other innovations and technical modifications designed and introduced to attempt to realize this goal. Pain after hemorrhoidectomy is expected. The reason for the exquisite tenderness after hemorrhoidectomy is undoubtedly related to the anatomy and intended function of the anus. The lining of the anal canal is certainly among the most richly innervated tissue in the digestive tract. It has the ability to sense temperature, vibration, stretch, noxious stimuli, and, very importantly, to help differentiate among gas, liquid, and solid material.2,3 As anyone who has had a meal rich in capsicum can attest, the next day’s bowel movement can often be an excruciating experience. So it is easy to imagine the pain associated with multiple incisions and suture lines overlapping from the anoderm to the anal mucosa. Adding to this trauma is, of course, the edema and perhaps acute subclinical infection or inflammation. Milito and colleagues,4 and, subsequently, the group from St Marks Hospital5 have documented in prospective randomized trials that the use of oral metronidazole after hemorrhoidectomy indeed significantly reduces pain, perhaps because it limits the amount of postoperative infectious-related subclinical inflammation. Traditionally, first-degree and second-degree hemorrhoids were treated by conservative nonoperative measures including increased dietary fiber and fluid, rubber band ligation,6 bipolar diathermy,7 injection sclerotherapy,8 and infrared coagulation.9 Patients with third- and fourth-degree hemorrhoids are generally advised to undergo surgical treatment, which has traditionally meant extirpation.10 As I have already alluded to, many treatments have appeared and disappeared over the last sev-
© 2001 by the American College of Surgeons Published by Elsevier Science Inc.
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operative oral analgesics was significantly less after diathermy as compared with scissors hemorrhoidectomy, there were no differences between the groups relative to the use of intramuscular or topical analgesics. Accordingly, this scientific scrutiny failed to prove the initial claims. So cryotherapy was abandoned because of draining wounds and significant discomfort, laser was largely relegated to the history books because of delayed wound healing, and diathermy has never been universally adopted because pain is only significantly reduced as compared with scissors hemorrhoidectomy, contingent on which aspects of pain are measured and how they are quantified. More recent innovations such as the monopolar shears and the ultrasonic scalpel have not yet been fully tested to either endorse or refute the initial claims. The other common denominator of all of these methods is that they excise, destroy, or ablate the hemorrhoidal tissue, removing or ligating the arterial and venous supplies. The prolapsing conjoined tendons and hemorrhoidal tissue are removed or destroyed along with, quite obviously, the sensory-rich anoderm and anal mucosa. In this issue of the Journal of the American College of Surgeons, Arnaud and coworkers1 have described a paradigm shift in the treatment of hemorrhoids. The technique of stapling for hemorrhoids began as not new. The concept was initially presented by Donald Peck from San Jose, CA, approximately 14 years ago.22 Peck described a stapled hemorrhoidectomy in which the hemorrhoidal tissue was removed by the application of two circumferential purse-string sutures and the subsequent firing of a circular stapler. He has continued to use the technique, and now has experience in more than 250 patients (Peck, personal communication, March 2001), which is quite different from the technique subsequently performed and reported by Longo23 and Milito and associates.24 In the Longo-Milito procedure for prolapsing hemorrhoids (PPH), the blood supply to the hemorrhoids is interrupted, but the actual arteriovenous malformations are left in situ. The hemorrhoids themselves are withdrawn in a cephalad direction, essentially accomplishing an anopexy, whereas the technique described by Peck had the theoretical risks of both anal canal stenosis and anal mucosal prolapse (Whitehead deformity). The Longo-Milito technique obviated these concerns by placing the staple line approximately 4 cm cephalad to the dentate line. This placement and retention of the hemorrhoids should, at least in theory, allow
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significantly better postoperative sensory function for the patient along with fewer disturbances in continence, a lower chance of anal stenosis as compared with extirpative hemorrhoidectomy, and obviously less pain than would be involved by creating multiple incisions and suture lines in the anoderm and anal mucosa. But the theoretical risks of the procedure are obviously first and foremost, failure to actually treat rectal bleeding and prolapse, and second, the failure of the technique to adequately address any associated component. As the technique spread from Palermo and Rome through the rest of Italy a variety of measures were taken to ensure placement of the purse string at this critical level of approximately 4–5 cm cephalad to the dentate line. Carriero25 described the use of the Lone Star retractor (Lone Star Medical Products Inc, Houston, TX) to efface the anus to allow easier placement of the purse string. But, the simplest and most reliable method has been the kit made available and provided with the specially designed 33-mm circular stapler (PPH kit, Ethicon Endo-Surgery, Inc, Cincinnati, OH). As the procedure became easier and more consistent, Ethicon EndoSurgery, Inc, helped to ensure the consistency in technique by having surgeons trained at a variety of locations, including Kronach, Germany, with Thorolf Hager and Linko¨ping, Sweden, with Per-Olof Nystrom. Thousands, if not tens of thousands of these procedures have been performed in the last few years in Europe and excellent results have been anecdotally reported by these many skilled European surgeons. Rather than dwelling on the anecdotal experiences and large personal series it is best to focus on the few prospective randomized trials. Arnaud and colleagues have provided a very nice table, which outlines the three first prospective randomized trials. The common denominator of these studies is that each of them has shown in a carefully designed, prospectively randomized, scientifically scrutinized trial that the pain and disability after the PPH is significantly less than that found after standard Milligan Morgan26,27 and Ferguson28 hemorrhoidectomies. A similar prospective randomized multicenter trial has been designed and is now underway in the United States (Honigsberg B, personal communication, March 2001). The main study objectives are to demonstrate at least a 50% reduction in postoperative pain during the first 14 days and to show equivalence of recurrence rates within 1 year. Secondary endpoints include in the perioperative period the length of operation,
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estimated blood loss, and length of any hospital stay along with the occurrence of any adverse events. Pain after the first bowel movements will be quantified, as will the use of narcotic analgesics and any occurrence of fecal impaction. A fecal incontinence-related quality of life score will be obtained. The study will be limited to patients over age 18 with prolapsing internal hemorrhoids. A total of 400 patients will be enrolled from 12 centers in the United States, including Cleveland Clinic Florida. In order for investigators to participate they must have undergone a baseline standardized training as discussed above watching the performance of the procedure by Professor Hager, followed by performance of the procedure in a supervised manner by him, and then practice of a minimum of 10 PPH operations before participation in the protocol. In this manner, hopefully the results will be uniform and consistent and will not include the “learning curve.” Indeed, the learning curve with this operation is not very different from that expected with other operations. Recent examples include port site recurrence after laparoscopic colectomy for attempted cure for colorectal cancer. Although initial rates were as high as 21%,29 more recently recurrence rates have been consistently less than 1%.30 A second example is the rate of clinical anastomotic leak after ileal pouch anal anastomosis, which was initially more than 25%31 and is now well under 5%.32,33 A third example is the incidence of sepsis requiring explanation of the artificial bowel sphincter, which decreased from approximately 33% to 15%.34,35 A certain baseline incidence of complications is expected even after the “learning curve” has been surpassed, which for standard excision of hemorrhoids includes bleeding in 2% to 4% of patients, after reoperations between 0.8% and 1.3%, urinary retention in 10% to 32%, fecal impaction in less than 1%, anal stenosis in 1%, and recurrence in less than 1%.3 In our initial pilot series of 10 patients at Cleveland Clinic Florida, 6 women and 4 men of a mean age of 54 years (range 31 to 83 years) had a mean duration of symptoms of 3.8 years (range 1 to 16 years) and all presented with bleeding, grade III prolapsing internal hemorrhoids. The operation was performed in all cases as an outpatient under general anesthesia in a prone jackknife position with the proximate PPH stapler kit (Ethicon Endo-Surgery, Inc, Cincinnati, OH). The mean operative time was 34 minutes (range 10 to 50 minutes). Intraoperative complications included one incomplete donut and seven cases of
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suture line requiring reinforcement for bleeding, which undoubtedly contributed to the increased operative time. But only one patient experienced postoperative bleeding, two urinary retention, and one pyrexia. Although two patients with pain required hospitalization, four patients reported that they had no postoperative pain and in fact took no postoperative analgesic, and the other four patients reported only mild pain, which required only acetaminophen for pain control. At a mean followup of 54 days (range 5 to 120 days) one patient experienced recurrence and two patients reported urgency. All three of these patients were operated on earlier in the experience and these problems may well have been attributed to excessively distal placement of the pursestring suture. The reason for the longer length of operative time in our series than that reported by Arnaud and colleagues or the other three prospective randomized trials in which that parameter is reported may have been the need for suture reinforcement of the suture line in 70% of our cases. It may be that either we did not hold the stapler closed long enough to include the tissue, as advocated by Longo, or that we are more paranoid than our European and Asian counterparts about bleeding at the staple line. I believe that the extra time was attributable to this meticulous suture reinforcement. But our results were completely consistent with those reported by Arnaud and the three prospective randomized trials. The Arnaud study included 59.3% of patients who required analgesics for less than 2 days, our study included 80% of patients who required either no pain medication or only acetaminophen, and the study by Mehigan and colleagues27 reported that 55% of patients required no opiates after their stapled hemorrhoidectomies. These figures of 55%, 59.3%, and 80% are strikingly similar and lend credence to the significant reductions in pain also reported by Rowsell and coworkers28 and Ho and associates.26 But as noted by Arnaud, not all of the results have been universally satisfactory. Cheetham and colleagues36 have reported that 5 of 16 patients (31%) developed symptoms of pain and fecal urgency, which persisted for at least 15 months after surgery, causing the randomized trial to be suspended. Like the early days of laparoscopy, other anecdotal complications have been verbally reported although not published. But also like laparoscopy, the data of Arnaud and colleagues are certainly in concert with the rapidly enlarging body of evidence suggesting that the PPH does
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allow a significantly less painful surgical method of treating third-degree hemorrhoids. I certainly must agree with the conclusion of Arnaud and coworkers, which is virtually identical to the conclusions of Rowsell and colleagues, Ho and associates, and Mehigan and colleagues that the PPH is a significantly less painful alternative to excisional hemorrhoidectomy and, accordingly, is associated with an earlier return to normal activity. But I also agree with all of these other authors that although early symptom control and functional outcomes appear normal, longterm symptomatic and functional outcomes require further study. Certainly the possibility of an increased rate of recurrence with longer followup is possible. Although, as with any new instrument or technique, the potential for complications through improper use exists. Hopefully, through appropriate training and education these problems can be minimized or obviated. Perhaps the prospective randomized trials currently underway in North America will help answer these questions. The other issue, which needs to be more fully explored, is the fate of any associated external component. Although Longo claims that the external component tends to withdraw within the anus after an appropriately performed PPH,23 other surgeons have advocated concomitant excision of any external component at the time of PPH. This answer to this question remains elusive and certainly warrants investigation. Pending the outcomes of these various trials, I am very optimistic that the PPH may finally offer patients suffering from thirddegree hemorrhoids a painless or at least relatively painfree method of addressing their troubling pathology. In my view the worst-case scenario might be a higher rate of recurrence of the disease after some disease-free interval. But given the significant pain, morbidity, and disability associated with standard hemorrhoidectomy, it is not unreasonable to hypothesize that like rubber band ligation, the PPH could be repeated at periodic intervals. Given the fact that it can be quickly performed on an outpatient basis with little morbidity and high patient satisfaction, repeat procedures may be preferred to excisional hemorrhoidectomy. Having been fortunate enough to have been a guest in Italy many times since I first heard Dr Longo describe this technique in Modena,37 I must confess that my attitude has shifted from complete incredulity and disbelief to significant skepticism to guarded optimism to, now, marked enthusiasm. What has changed during that
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interval? First, the number of procedures that have been performed; second, the number of surgeons who have performed the procedure; third, the available body of prospective randomized and large prospective series; fourth, the ability to observe these procedures and, more importantly, to speak with and examine patients who have had them; and last, the opportunity to perform the procedure myself. I am pleased that Ethicon Endosurgery, Inc, is supporting the prospective randomized trial and, more importantly, is ensuring the appropriate training and credentialing of surgeons performing this technique. Through this type of partnership, we will hopefully be able to afford our patients the best results. In the meantime, although the quest for painless surgical treatment of hemorrhoids continues, I am hopeful that there will be an end to the pain in the end. Acknowledgment: Ethicon Endo-Surgery, Inc, provides educational and research support to Cleveland Clinic Florida.
REFERENCES 1. Arnaud JP, 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: 155–159. 2. Jorge JMN. Anorectal anatomy and physiology. In: Beck DE, Wexner SD, eds. Fundamentals of anorectal surgery. London: WB Saunders Company Ltd; 1998;1–24. 3. Beck DE. Hemorrhoidal disease. In: Beck DE, Wexner SD, eds. Fundamentals of anorectal surgery. London: WB Saunders Company Ltd; 1998;237–253. 4. Milito G, Cortese F, Brancaleone C, Cascione CU. The role of prophylactic metronidazole in the management of postoperative pain after haemorrhoidectomy. Tech Coloproctol 1996;4:84–86. 5. Carapeti EA, Kamm MA, McDonald PJ, Phillips RKS. Double blind randomised controlled trial of effect of metronidazole on pain after day-case haemorrhoidectomy. Lancet 1998;351:169– 172. 6. Murie JA, Sim AJW, Mackenzie I. Rubberband ligation versus haemorrhoidectomy for prolapsing haemorrhoids: a long term prospective clinical trial. Br J Surg 1982;69:536–538. 7. Griffith CDM, Morris DL, Wherry D, et al. Outpatient treatment of haemorrhoids: a randomized trial comparing contact bipolar diathermy with rubber band ligation. Coloproctology 1987;6:322–334. 8. Varma JS, Chung SC, Li AK. Prospective randomised comparison of current coagulation and injection sclerotherapy for the outpatient treatment of haemorrhoids. Int J Colorectal Dis 1991;6:42–45. 9. Leicester RJ, Nichols RJ, Mann CV. Infrared coagulation: a new treatment for haemorrhoids. Dis Colon Rectum 1981;24:602. 10. Corman ML, ed. Colon and rectal surgery. 4th ed. Philadelphia: Lippincott-Raven; 1998;147–205.
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11. Smith LE, Goodreau JJ, Fouty WJ. Operative haemorrhoidectomy versus cryodestruction. Dis Colon Rectum 1979;22:10–16. 12. Lewis AM, Rogers HS, Leighton M. Trial of maximal anal dilation, cryotherapy and elastic band ligation as alternatives to haemorrhoidectomy in treatment of large prolapsing haemorrhoids. Br J Surg 1983;70:45–46. 13. Pezzangora S. Presented at the 6th biennial international meeting of coloproctology. Ivrea, Italy, April 5–8, 2000. 14. Armstrong DN, Ambroze WL, Schertzer ME, Orangio GR. Harmonic scalpel versus electrocautery hemorrhoidectomy: a prospective evaluation. Dis Colon Rectum 2001;44:556–564. 15. Kahn S, Pawlak FE, Eggenberger JC, et al. Surgical treatment of hemorrhoids: prospective randomized trial comparing closed excisional hemorrhoidectomy and the harmonic scalpel technique of exisional hemorrhoidectomy. Dis Colon Rectum 2001; 44:845–849. 16. Leff EI. Hemorrhoidectomy—laser versus nonlaser: outpatient surgical experience. Dis Colon Rectum 1992;35:743–746. 17. Senagore A, Mazier WP, Luchtefeld MA, et al. Treatment of advanced haemorrhoidal disease: a prospective randomized comparison of cold scalpel vs Nd:YAG laser. Dis Colon Rectum 1995;36:1042–1049. 18. Sharif HI, Lee L, Alexander-Williams J. Diathermy hemorrhoidectomy. Int J Colorect Dis 1991;6:217–219. 19. Goligher J. Haemorrhoids or piles. In: Goligher J, ed. Surgery of the anus, rectum, and colon. 5th ed. London: Bailliere Tindall; 1984. 20. Ibrahim S, Tsang C, Lee YL, et al. Prospective randomized trial comparing pain and complications between diathermy and scissors for closed hemorrhoidectomy. Dis Colon Rectum 1998;41: 1418–1420. 21. Seow-Choen F, Ho Y-H, Ang H-G, Goh H-S. Prospective randomized trial comparing pain and clinical function after conventional scissors excision/ligation vs. diathermy excision without ligation for symptomatic prolapsed hemorrhoids. Dis Colon Rectum 1992;35:1165–1169. 22. Peck DA. Endoanal stapled hemorrhoidectomy (Poster). Presented at American Society of Colon and Rectal Surgeons. Washington, DC, April 5–10, 1987. 23. Longo A. Treatment of hemorrhoids disease by reduction of mucosa and hemorrhoidal prolapse with circular suturing device: a new procedure. Proceedings of the 6th World Congress of Endoscopic Surgery. Rome, Italy, June 3–6, 1998. 24. Milito G, Cortese F, Casciani CU. Surgical treatment of mucosal prolapse and haemorrhoids by stapler, Proceedings of the 6th
25.
26.
27.
28.
29. 30.
31. 32.
33.
34. 35.
36. 37.
World Congress of Endoscopic Surgery. Rome, Italy, June 3–6, 1998. Carriero A. Stapled distal rectal mucosal prolapsectomy by Lone Star Retractor™ for haemorrhoidal prolapse. Surgical technique by Alfonso Carriero. Rome: Monologue Arkon Medical Technologies: 2001. Ho YH, Cheong WK, Tsang C, et al. Stapled hemorrhoidectomy—Cost effectiveness. Randomized controlled trial including incontinence scoring, anorectal manometry, and endoanal ultrasound assessment at up to three months. Dis Colon Rectum 2000;43:1666–1675. Mehigan BJ, Monson JRT, Hartley JE. Stapling procedure for haemorrhoids versus Milligan-Morgan haemorrhoidectomy: randomised controlled trial. Lancet 2000;355:782–785. Rowsell M, Bello M, Hemingway DM. Circumferential mucosectomy (stapled haemorrhoidectomy) versus conventional haemorrhoidectomy: randomised controlled trial. Lancet 2000; 355:779–781. Berends FJ, Kazemier G, Bonjer HJ, Lange JF. Subcutaneous metastases after laparoscopic colectomy. Lancet 1994;344:58. Wexner SD (guest editor). Surgical oncology clinics of North America: laparoscopic and endoscopic surgery in oncology. Philadelphia: W.B. Saunders (in press). Wong WD, Rothenberger DA, Goldberg SM. Ileoanal pouch procedures. Curr Probl Surg 1985;22:1–78. Marcello PW, Milsom JW, Wong SK, et al. Laparoscopic restorative proctocolectomy: case-matched comparative study with open restorative proctocolectomy. Dis Colon Rectum 2000;43: 604–608. Soravia C, Klein L, Berk T, et al. Comparison of ileal pouch-anal anastomosis in patients with familial adenomatous polyposis. Dis Colon Rectum 1999;42:1028–1033. Wong WD, Jensen LL, Bartolo DC, Rothenberger DA. Artificial anal sphincter. Dis Colon Rectum 1996;39:1345–1351. O’Brien PE, Skinner S. Restoring control: the Acticon Neosphincter artificial bowel sphincter in the treatment of anal incontinence. Dis Colon Rectum 2000;43:1213–1216. Cheetham MJ, Mortensen NJM, Nystrom PO, et al. Persistent pain and faecal urgency after stapled haemorrhoidectomy. Lancet 2000;356:730–733. Longo A. Operative techniques of hemorrhoidectomy. Presented at 4th National Congress of UCP Club. Modena, Italy, November 27–28, 1997.
The Quest for Painless Surgical Treatment of Hemorrhoids Continues Steven D Wexner, MD, FACS, FRCS, FRCS (Ed), Fort Lauderdale, FL
eral decades, each initially touted as the newest method to perform a hemorrhoidectomy without causing significant postoperative suffering from pain. This list includes cryotherapy11,12 and a plethora of instruments designed to remove the hemorrhoidal tissue while minimizing postoperative pain. The instruments that have been introduced to replace standard Milligan Morgan or Ferguson hemorrhoidectomy include the bipolar scissors, the diathermy instrument, the carbon dioxide and neodymium yag lasers, and, more recently, the monopolar coagulator (LigaSure, Valleylab, Boulder, CO),13 and the ultrasonic scalpel.14,15 The common denominator of each of these methods is that after the initial enthusiasm, detailed scientific scrutiny failed to confirm the preliminary claims, so widespread adoption never came to fruition. Examples include the cryotherapy trial performed by Smith and colleagues,11 and the experiences of Leff16 and subsequently Senagore and associates17 of laser hemorrhoidectomy. In fact, the latter study was a well-constructed large prospective randomized trial in which the only significant difference between the standard excisional technique and the laser was more prolonged wound healing in the laser group. The diathermy technique was originally advocated by John Alexander-Williams and coworkers18 at the General Hospital in Birmingham and described by Professor John Goligher of Leeds.19 Unlike some of the other techniques, two recent prospective randomized trials from the Singapore General Hospital have both supported that diathermy hemorrhoidectomy was associated with less pain than was scissors hemorrhoidectomy.20,21 But even these two trials failed to conclusively demonstrate a significant reduction in pain by all measures at all time points. Specifically, the study by Ibrahim and colleagues20 was unable to identify a significant difference in pain requirements during the first 24 hours after surgery, which is often the most critical point, because it is during that time period that severe pain may exacerbate urinary retention in male patients. Similarly, the Ho and associates study,21 found that although the use of post-
Even through the relatively few decades during which I have been educated and begun to practice colorectal surgery, I have seen numerous new techniques championed to reduce the pain associated with the surgical treatment of hemorrhoids. (See article in current issue by Arnaud and colleagues.)1 There is no reason to suppose that the many decades and, in fact, centuries before my participation did not include multiple other innovations and technical modifications designed and introduced to attempt to realize this goal. Pain after hemorrhoidectomy is expected. The reason for the exquisite tenderness after hemorrhoidectomy is undoubtedly related to the anatomy and intended function of the anus. The lining of the anal canal is certainly among the most richly innervated tissue in the digestive tract. It has the ability to sense temperature, vibration, stretch, noxious stimuli, and, very importantly, to help differentiate among gas, liquid, and solid material.2,3 As anyone who has had a meal rich in capsicum can attest, the next day’s bowel movement can often be an excruciating experience. So it is easy to imagine the pain associated with multiple incisions and suture lines overlapping from the anoderm to the anal mucosa. Adding to this trauma is, of course, the edema and perhaps acute subclinical infection or inflammation. Milito and colleagues,4 and, subsequently, the group from St Marks Hospital5 have documented in prospective randomized trials that the use of oral metronidazole after hemorrhoidectomy indeed significantly reduces pain, perhaps because it limits the amount of postoperative infectious-related subclinical inflammation. Traditionally, first-degree and second-degree hemorrhoids were treated by conservative nonoperative measures including increased dietary fiber and fluid, rubber band ligation,6 bipolar diathermy,7 injection sclerotherapy,8 and infrared coagulation.9 Patients with third- and fourth-degree hemorrhoids are generally advised to undergo surgical treatment, which has traditionally meant extirpation.10 As I have already alluded to, many treatments have appeared and disappeared over the last sev-
© 2001 by the American College of Surgeons Published by Elsevier Science Inc.
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ISSN 1072-7515/01/$21.00 PII S1072-7515(01)00997-8
Vol. 193, No. 2, August 2001
operative oral analgesics was significantly less after diathermy as compared with scissors hemorrhoidectomy, there were no differences between the groups relative to the use of intramuscular or topical analgesics. Accordingly, this scientific scrutiny failed to prove the initial claims. So cryotherapy was abandoned because of draining wounds and significant discomfort, laser was largely relegated to the history books because of delayed wound healing, and diathermy has never been universally adopted because pain is only significantly reduced as compared with scissors hemorrhoidectomy, contingent on which aspects of pain are measured and how they are quantified. More recent innovations such as the monopolar shears and the ultrasonic scalpel have not yet been fully tested to either endorse or refute the initial claims. The other common denominator of all of these methods is that they excise, destroy, or ablate the hemorrhoidal tissue, removing or ligating the arterial and venous supplies. The prolapsing conjoined tendons and hemorrhoidal tissue are removed or destroyed along with, quite obviously, the sensory-rich anoderm and anal mucosa. In this issue of the Journal of the American College of Surgeons, Arnaud and coworkers1 have described a paradigm shift in the treatment of hemorrhoids. The technique of stapling for hemorrhoids began as not new. The concept was initially presented by Donald Peck from San Jose, CA, approximately 14 years ago.22 Peck described a stapled hemorrhoidectomy in which the hemorrhoidal tissue was removed by the application of two circumferential purse-string sutures and the subsequent firing of a circular stapler. He has continued to use the technique, and now has experience in more than 250 patients (Peck, personal communication, March 2001), which is quite different from the technique subsequently performed and reported by Longo23 and Milito and associates.24 In the Longo-Milito procedure for prolapsing hemorrhoids (PPH), the blood supply to the hemorrhoids is interrupted, but the actual arteriovenous malformations are left in situ. The hemorrhoids themselves are withdrawn in a cephalad direction, essentially accomplishing an anopexy, whereas the technique described by Peck had the theoretical risks of both anal canal stenosis and anal mucosal prolapse (Whitehead deformity). The Longo-Milito technique obviated these concerns by placing the staple line approximately 4 cm cephalad to the dentate line. This placement and retention of the hemorrhoids should, at least in theory, allow
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significantly better postoperative sensory function for the patient along with fewer disturbances in continence, a lower chance of anal stenosis as compared with extirpative hemorrhoidectomy, and obviously less pain than would be involved by creating multiple incisions and suture lines in the anoderm and anal mucosa. But the theoretical risks of the procedure are obviously first and foremost, failure to actually treat rectal bleeding and prolapse, and second, the failure of the technique to adequately address any associated component. As the technique spread from Palermo and Rome through the rest of Italy a variety of measures were taken to ensure placement of the purse string at this critical level of approximately 4–5 cm cephalad to the dentate line. Carriero25 described the use of the Lone Star retractor (Lone Star Medical Products Inc, Houston, TX) to efface the anus to allow easier placement of the purse string. But, the simplest and most reliable method has been the kit made available and provided with the specially designed 33-mm circular stapler (PPH kit, Ethicon Endo-Surgery, Inc, Cincinnati, OH). As the procedure became easier and more consistent, Ethicon EndoSurgery, Inc, helped to ensure the consistency in technique by having surgeons trained at a variety of locations, including Kronach, Germany, with Thorolf Hager and Linko¨ping, Sweden, with Per-Olof Nystrom. Thousands, if not tens of thousands of these procedures have been performed in the last few years in Europe and excellent results have been anecdotally reported by these many skilled European surgeons. Rather than dwelling on the anecdotal experiences and large personal series it is best to focus on the few prospective randomized trials. Arnaud and colleagues have provided a very nice table, which outlines the three first prospective randomized trials. The common denominator of these studies is that each of them has shown in a carefully designed, prospectively randomized, scientifically scrutinized trial that the pain and disability after the PPH is significantly less than that found after standard Milligan Morgan26,27 and Ferguson28 hemorrhoidectomies. A similar prospective randomized multicenter trial has been designed and is now underway in the United States (Honigsberg B, personal communication, March 2001). The main study objectives are to demonstrate at least a 50% reduction in postoperative pain during the first 14 days and to show equivalence of recurrence rates within 1 year. Secondary endpoints include in the perioperative period the length of operation,
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estimated blood loss, and length of any hospital stay along with the occurrence of any adverse events. Pain after the first bowel movements will be quantified, as will the use of narcotic analgesics and any occurrence of fecal impaction. A fecal incontinence-related quality of life score will be obtained. The study will be limited to patients over age 18 with prolapsing internal hemorrhoids. A total of 400 patients will be enrolled from 12 centers in the United States, including Cleveland Clinic Florida. In order for investigators to participate they must have undergone a baseline standardized training as discussed above watching the performance of the procedure by Professor Hager, followed by performance of the procedure in a supervised manner by him, and then practice of a minimum of 10 PPH operations before participation in the protocol. In this manner, hopefully the results will be uniform and consistent and will not include the “learning curve.” Indeed, the learning curve with this operation is not very different from that expected with other operations. Recent examples include port site recurrence after laparoscopic colectomy for attempted cure for colorectal cancer. Although initial rates were as high as 21%,29 more recently recurrence rates have been consistently less than 1%.30 A second example is the rate of clinical anastomotic leak after ileal pouch anal anastomosis, which was initially more than 25%31 and is now well under 5%.32,33 A third example is the incidence of sepsis requiring explanation of the artificial bowel sphincter, which decreased from approximately 33% to 15%.34,35 A certain baseline incidence of complications is expected even after the “learning curve” has been surpassed, which for standard excision of hemorrhoids includes bleeding in 2% to 4% of patients, after reoperations between 0.8% and 1.3%, urinary retention in 10% to 32%, fecal impaction in less than 1%, anal stenosis in 1%, and recurrence in less than 1%.3 In our initial pilot series of 10 patients at Cleveland Clinic Florida, 6 women and 4 men of a mean age of 54 years (range 31 to 83 years) had a mean duration of symptoms of 3.8 years (range 1 to 16 years) and all presented with bleeding, grade III prolapsing internal hemorrhoids. The operation was performed in all cases as an outpatient under general anesthesia in a prone jackknife position with the proximate PPH stapler kit (Ethicon Endo-Surgery, Inc, Cincinnati, OH). The mean operative time was 34 minutes (range 10 to 50 minutes). Intraoperative complications included one incomplete donut and seven cases of
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suture line requiring reinforcement for bleeding, which undoubtedly contributed to the increased operative time. But only one patient experienced postoperative bleeding, two urinary retention, and one pyrexia. Although two patients with pain required hospitalization, four patients reported that they had no postoperative pain and in fact took no postoperative analgesic, and the other four patients reported only mild pain, which required only acetaminophen for pain control. At a mean followup of 54 days (range 5 to 120 days) one patient experienced recurrence and two patients reported urgency. All three of these patients were operated on earlier in the experience and these problems may well have been attributed to excessively distal placement of the pursestring suture. The reason for the longer length of operative time in our series than that reported by Arnaud and colleagues or the other three prospective randomized trials in which that parameter is reported may have been the need for suture reinforcement of the suture line in 70% of our cases. It may be that either we did not hold the stapler closed long enough to include the tissue, as advocated by Longo, or that we are more paranoid than our European and Asian counterparts about bleeding at the staple line. I believe that the extra time was attributable to this meticulous suture reinforcement. But our results were completely consistent with those reported by Arnaud and the three prospective randomized trials. The Arnaud study included 59.3% of patients who required analgesics for less than 2 days, our study included 80% of patients who required either no pain medication or only acetaminophen, and the study by Mehigan and colleagues27 reported that 55% of patients required no opiates after their stapled hemorrhoidectomies. These figures of 55%, 59.3%, and 80% are strikingly similar and lend credence to the significant reductions in pain also reported by Rowsell and coworkers28 and Ho and associates.26 But as noted by Arnaud, not all of the results have been universally satisfactory. Cheetham and colleagues36 have reported that 5 of 16 patients (31%) developed symptoms of pain and fecal urgency, which persisted for at least 15 months after surgery, causing the randomized trial to be suspended. Like the early days of laparoscopy, other anecdotal complications have been verbally reported although not published. But also like laparoscopy, the data of Arnaud and colleagues are certainly in concert with the rapidly enlarging body of evidence suggesting that the PPH does
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allow a significantly less painful surgical method of treating third-degree hemorrhoids. I certainly must agree with the conclusion of Arnaud and coworkers, which is virtually identical to the conclusions of Rowsell and colleagues, Ho and associates, and Mehigan and colleagues that the PPH is a significantly less painful alternative to excisional hemorrhoidectomy and, accordingly, is associated with an earlier return to normal activity. But I also agree with all of these other authors that although early symptom control and functional outcomes appear normal, longterm symptomatic and functional outcomes require further study. Certainly the possibility of an increased rate of recurrence with longer followup is possible. Although, as with any new instrument or technique, the potential for complications through improper use exists. Hopefully, through appropriate training and education these problems can be minimized or obviated. Perhaps the prospective randomized trials currently underway in North America will help answer these questions. The other issue, which needs to be more fully explored, is the fate of any associated external component. Although Longo claims that the external component tends to withdraw within the anus after an appropriately performed PPH,23 other surgeons have advocated concomitant excision of any external component at the time of PPH. This answer to this question remains elusive and certainly warrants investigation. Pending the outcomes of these various trials, I am very optimistic that the PPH may finally offer patients suffering from thirddegree hemorrhoids a painless or at least relatively painfree method of addressing their troubling pathology. In my view the worst-case scenario might be a higher rate of recurrence of the disease after some disease-free interval. But given the significant pain, morbidity, and disability associated with standard hemorrhoidectomy, it is not unreasonable to hypothesize that like rubber band ligation, the PPH could be repeated at periodic intervals. Given the fact that it can be quickly performed on an outpatient basis with little morbidity and high patient satisfaction, repeat procedures may be preferred to excisional hemorrhoidectomy. Having been fortunate enough to have been a guest in Italy many times since I first heard Dr Longo describe this technique in Modena,37 I must confess that my attitude has shifted from complete incredulity and disbelief to significant skepticism to guarded optimism to, now, marked enthusiasm. What has changed during that
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interval? First, the number of procedures that have been performed; second, the number of surgeons who have performed the procedure; third, the available body of prospective randomized and large prospective series; fourth, the ability to observe these procedures and, more importantly, to speak with and examine patients who have had them; and last, the opportunity to perform the procedure myself. I am pleased that Ethicon Endosurgery, Inc, is supporting the prospective randomized trial and, more importantly, is ensuring the appropriate training and credentialing of surgeons performing this technique. Through this type of partnership, we will hopefully be able to afford our patients the best results. In the meantime, although the quest for painless surgical treatment of hemorrhoids continues, I am hopeful that there will be an end to the pain in the end. Acknowledgment: Ethicon Endo-Surgery, Inc, provides educational and research support to Cleveland Clinic Florida.
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