Stapled Rectal Mucosectomy vs.

Closed Hemorrhoidectomy
A Randomized, Clinical Trial
Jose Manuel Correa-Rovelo, M.D.,* Oscar Tellez, M.D.,* Leoncio Obrego M.D.,* n, Adriana Miranda-Gomez, M.D.,* Segundo Moran, M.D.
From the *Colon and Rectum Clinic and the Gastroenterology Clinic, Medica Sur Hospital, Mexico City, Mexico
INTRODUCTION: We compared the safety and clinical outcome between stapled rectal mucosectomy and closed hemorrhoidectomy for the surgical treatment of noncomplicated hemorrhoidal disease. METHODS: Eighty-four patients with Grade III and IV hemorrhoidal disease were randomly assigned to two groups: 1) stapled rectal mucosectomy group (n 42) and 2) closed hemorrhoidectomy group (n 42). Postoperative pain, analgesic use, symptoms, disability, early and late complications, and patient satisfaction were evaluated, among others. Follow-up was six months. RESULTS: Eighty-four patients, averaging 45 9 years of age, underwent surgery. Two were lost to followup. Length of surgery and disability, postoperative pain, and use of analgesics were significantly less for patients in the stapled rectal mucosectomy group. In the closed hemorrhoidectomy group early complications were more frequent but not statistically significant, and there were no statistically significant differences regarding the frequency of late complications. No serious complications were reported in either group. Closed hemorrhoidectomy proved to be superior for bleeding control (95.1 percent closed hemorrhoidectomy vs. 80.5 percent stapled rectal mucosectomy; P 0.04). Patient satisfaction was similar in the two groups, but stapled rectal mucosectomy patients were more willing to undergo the same procedure (P 0.02). CONCLUSION: Both stapled rectal mucosectomy and closed hemorrhoidectomy are safe procedures. Closed hemorrhoidectomy was superior for bleeding control in Grade III and IV hemorrhoidal disease, but more painful and disabling than stapled rectal mucosectomy. [Key words: Stapled rectal mucosectomy; Hemorrhoids; Hemorrhoidectomy] Correa-Rovelo JM, Tellez O, Obregon L, Miranda-Gomez A, Moran S. Stapled rectal mucosectomy vs. closed hemorrhoidectomy: a randomized, clinical trial. Dis Colon Rectum 2002;45:13671375.

emorrhoidal disease (HD) is very common among patients older than the age of 50.1,2 Treatment has varied and been controversial over the years and includes alternatives such as infrared ray photocoagulation, electrocoagulation, sclerotherapy
Read at the meeting of The American Society of Colon and Rectal Surgeons, San Diego, California, June 2 to 7, 2001. Address reprint requests to Dr. Correa-Rovelo, Puente de Piedra #150 Torre 2-610, Colonia Toriello Guerra, Delegacion Tlalpan, Mexico 14050. DOI: 10.1097/01.DCR.0000029761.56497.08

and closed or open hemorrhoidectomy. Although each has its specific indications, closed or open hemorrhoidectomy is currently considered the most effective treatment and has few complications. Nonetheless, the associated postoperative pain and disability make it an unpopular choice with patients.36 Anopexy, or stapled rectal mucosectomy (SRM), is an innovative procedure based on the principle of healing symptoms without affecting functions.7 Pescatori,8 in 1997, reported the resection of mucous prolapse by means of a circular stapler. The principles of SRM and his experience with 144 patients over a 3-year period were reported by Longo in 1998.7 With this technique, hemorrhoidal packs are relocated within the anal canal by means of a circumferential resection of the mucosa located over these packs, between the rectal ampulla and the anal canal.7 Theoretically, the blood flow from the different submucous ramifications of the hemorrhoidal arteries is reduced.9 Because the procedure is done from above the dentate line, part or all of the transitional epithelium is preserved. Therefore, postoperative pain is less than the pain caused by a hemorrhoidectomy, and the sensitivity of the anal canal is preserved.10,11 Advantages of this technique include minimal pain, early return to activities, and scarce morbidity, according to comparative clinical trials.1214 The safety of this method has recently been questioned after reports of persistent postoperative pain and fecal urgency following the procedure in patients followed up for a period of more than six months.15 Therefore, despite SRM being a promising technique, mediumterm and long-term comparative clinical trials between this procedure and traditional hemorrhoidectomy is required to determine its true therapeutic value.16 We designed a prospective, randomized study to evaluate the safety and clinical response of stapled rectal mucosectomy7 compared with closed

1367

1368

CORREA-ROVELO ET AL

Dis Colon Rectum, October 2002

hemorrhoidectomy17 (CH) in patients with uncomplicated Grade III and Grade IV hemorrhoidal disease.

PATIENTS AND METHODS

During a ten-month period we selected patients with nonthrombosed Grade III and IV HD that required resection of the three primary hemorrhoidal packs. A preoperative evaluation of continence and hemorrhoidal disease was performed. Four grades of continence18 and HD5 were established and verified by another colorectal surgeon. Demographics and clinical characteristics for the two groups are shown in Table 1. This clinical trial was approved by the ethics committee of our institution, and informed consent was obtained from each patient. Before this clinical trial, the team of surgeons performed SRM on 12 patients having Grade IIIV HD. Patients with anorectal comorbidity, previous anal surgery, or immunosuppression were excluded. Other causes of rectal bleeding were excluded by rectosigmoidoscopy or colonoscopy according to patient age and surgeons criteria. Patient symptoms were recorded. They were randomly assigned to two groups according to a list generated using random number tables: 1) stapled rectal mucosectomy (SRM) and 2) closed hemorrhoidectomy (CH). Patients were followed up for at least six months.

pivacaine was used in all patients except one from the SRM group, who required general anesthesia because of regional contraindication. All patients were operated on in the morning and in prone jackknife position. Complications and duration of the surgery were recorded. Stapled rectal mucosectomy was performed according to the surgical technique described by Longo.7 The 1-0 polypropylene pursestring suture was placed 4 to 5 cm over the dentate line. Bleeding spots were cauterized or suture-ligated with 3-0 polyglactin. We recorded the mean distance from the line of staples to the dentate line and the width of the resected mucosa doughnut. Closed hemorrhoidectomy was performed according to Fergusons17 technique for resection of the three primary hemorrhoids. Resected specimens from both groups were sent to the pathology department.

Postoperative Control
All patients were kept under observation for the first 24 hours. Regular diet was resumed four hours after the procedure. Analgesia was obtained with a 24-hour IV infusion of 0.8 mg/kg ketorolac and 0.5 g/kg fentanyl. An additional IV bolus of 0.5 mg/kg ketorolac was administered every eight hours as necessary. If additional pain control medication was required, an IV bolus of fentanyl 0.5 g/kg was administered as necessary. Intensity of postoperative pain was blindly measured every 8 hours by means of a 0 to 10 visual analog scale (0 no pain and 10 maximal pain experienced). Analgesic requirements and mean and maximum pain were recorded. At discharge patients were prescribed 10 mg

Technique
A phosphate enema and a 1.5-g dose of intravenous (IV) cefuroxime were administered an hour before the surgical procedure. Epidural anesthesia with heavy bu-

Table 1. Demographic Data and Clinical Characteristics Variable Mean age, yr, SD (range) Gender Male Female Hemorrhoidal disease Grade III Grade IV Mean time of evolution, mo, Comorbid conditions SRM (n 43.7 42) CH (n 46.6 42) P 0.14* 0.51

10 (27 67) 22 (52.4) 20 (47.6) 32 (76.2) 10 (23.8) 13.7 (12 60) 2 (4.8)

8.9 (34 77) 19 (45.2) 23 (54.8) 28 (66.7) 14 (33.3) 12.9 (18 68) 5 (11.9)

0.33 0.05* 0.43

SD (range)

31.9

38.1

SRM stapled rectal mucosectomy; CH closed hemorrhoidectomy; SD Figures are number and (percentage) unless otherwise specified. * Mann-Whitney U test. Chi-squared test. Fishers exact probability test.

standard deviation.

Vol. 45, No. 10

STAPLED RECTAL MUCOSECTOMY

1369

ketorolac orally (12 tablets three or four times per day), a laxative (sennosides A and B) to be used if necessary, and sitz baths.

Follow-Up
Postoperative pain, analgesic requirements, time to first bowel movement, symptoms, disability, recurrence, and patient satisfaction were evaluated (Tables 2 and 3). After discharge all patients were followed up every week for the first three weeks and then at two and six months. Thirty-one patients of the SRM group and 28 of the CH group were followed up from 7 to 14 months. A surgeon other than the treating surgeon performed the clinical evaluation. The following were blindly measured using a visual analog scale of 010: pain after 2 weeks and after 2 months, satisfaction regarding improvement or clearing of symptoms, and

the willingness to undergo the same surgery following the same procedure. Safety of the procedures was defined according to the frequency and the seriousness of complications encountered as compared with CH. Clinical response was defined according to symptom control. For statistical purposes asymptomatic patients were considered as a group and symptomatic patients were analyzed according to specific symptoms. Subjective improvement was not considered as a clinical response criterion. Recurrence of the disease was defined as symptom persistence that required additional treatment.

Statistical Analysis
Results are shown as mean standard deviation, ranges, and percentages. Intergroup analysis was performed according to the Mann-Whitney U test and

Table 2. Evaluation After Surgery Variable SRM (n 42) CH (n 42) P 0.001 0.001 0.001 0.001 0.001 0.001 0.001 0.002 0.001 0.048 0.15 0.001 0.061 0.62 1.0 1.0 0.12 0.49 1.0 1.0 1.0 1.0 1.0

Length of surgery 11.9 3.1 (718) 46.4 10.4 (30 60) Pain during first 24 hours (0 10)* Mean 2.8 1.4 (0 5.7) 5.5 1.4 (27.7) Maximum 4.6 2.1 (0 8) 7.2 1.7 (310) Extra ketorolac requirements first 21 (50.0) 42 (100) 24 hours Dosage (mg)* 15.7 16.5 (0 60) 84.3 25 (30 120) Extra fentanyl requirements first 0 12 (28.6) 24 hours Days taking ketorolac (10 mg 4.9 2.8 (114) 12.8 4.2 (528) tablets)* First bowel movement (hr)* 26.3 7.2 34.3 14.2 Symptoms at 2 weeks Pain (0 10)* 1.1 1.4 (0 4) 3.7 1.5 (0 6) Bleeding 14 (33.3%) 23 (54.8) Anal pruritus 10 (23.8) 16 (38.1) Length of disability (days)* 6.1 3.5 (221) 15.2 4.8 (730) Early complications 3 (7.1) 9 (21.4) Urinary retention 1 (2.4) 3 (7.1) Bleeding that required revision 1 (2.4%) 0 Submucosal hematoma 1 (2.4) 0 Wound dehiscence 0 4 (9.5%) Fecal impaction 0 2 (4.9%) Late complications 3 (7.1) 4 (9.5) Anal stricture 1 (2.4) 1 (2.4) Dyspareunia 1 (2.4) 0 Anal pruritus 1 (2.4) 2 (4.8) Anal incontinence 0 1 (2.4) SRM stapled rectal mucosectomy; CH closed hemorrhoidectomy. * Results expressed in mean standard deviation (range). Mann-Whitney U test. chi-squared test. Fishers exact probability test.

1370

Table 3. Results of Clinical Evaluation Preoperative (n 0.46 0.75 0.26 0.1 0.61 0.12 0.09* 9.0 1 (2.4) 1.6 (210) 8.9 39 (95.1) 0 1.1 (6 10) 32 (78) 1 0.11* 0.023 32 (78) 8 (19.5) 2 (4.9) 2 (4.9) 1 (2.5) 0 5 (12.2) CH 42) P (n P SRM (n 41) CH 41) SRM (n 41) Two Months After Surgery Last Follow-Up(6 14 Months) (n CH 41) 35 (85.4) 2 (4.9) 3 (7.3) 4 (9.8) 0 2 (4.9) 2 (4.9) P 0.39 CORREA-ROVELO ET AL 0.043 1 0.67 1 0.49 0.43

SRM (n 42)

Asymptomatic patients 31 (75.6) 28 (63.8) Symptoms Bleeding 42 (100) 42 (100) 6 (14.6) 5 (12.2) Discomfort or anal pain 22 (52.4) 17 (40.5) 0.27 2 (4.9) 6 (14.6) Anal pruritus 14 (33.3) 16 (38.1) 0.65 3 (7.3) 8 (19.5) Hemorrhoidal prolapse 42 (100) 42 (100) 0 0 Anal incontinence 0 1 (2.4) 1 1 (2.4) 3 (7.3) Presence of skin tags 35 (83.3) 37 (88.1) 0.53 Wounds healed 41 (100) 37 (90.2) Recurrence 0 0 Mean patient satisfaction 9.2 1.2 (310) 9.0 1 (6 10) (0 10), SD (range) Willingness to undergo the same surgery SRM stapled rectal mucosectomy; CH closed hemorrhoidectomy; SD standard deviation. Figures are number and (percent) unless other wise specified. * Mann-Whitney U test. Chi-squared test. Fishers exact probability test.

Dis Colon Rectum, October 2002

Vol. 45, No. 10

STAPLED RECTAL MUCOSECTOMY

1371

chi-squared or Fishers exact probability test. For analyzing each group, the Wilcoxon assigned ranges test and the McNemar or binomial test were used. Results were considered significant at P 0.05. Stata 6.0 software was used for statistical analysis (Stata Corporation, College Station, TX.)

RESULTS
Preoperative symptoms included bleeding, discomfort or anal pain, anal pruritus, hemorrhoidal prolapse, anal incontinence, and presence of skin tags. There was no difference in frequency of preoperative symptoms between the two groups (Table 3). A total of 84 patients underwent surgery. Forty-two patients were randomly assigned to the SRM group and 42 to the CH procedure. One patient from each group was lost to follow-up. Surgery was significantly shorter in the group of SRM patients. Fourteen of these (33.3 percent) required a hemostatic suture after firing the stapler. The mean distance between the line of staples and the dentate line was 28.9 3.3 (range, 2138) mm. All resected mucosa doughnuts were complete and 34.7 4.7 mm. in mean length. At histopathology of the resected mucosa and columnar epithelium was found in 20 patients (47.6 percent) and columnar and transitional epithelium in 22 (52.4 percent). No anoderm was found. Scarce smooth muscle fibers were found in the same proportion in the two groups (59.5 percent for SRM and 56.1 percent for CH). Mean and maximal postoperative pain, analgesic requirements, mean time before first bowel movement, length of disability, and early complications were significantly less for the SRM group than the CH group (Table 2). Two patients in the SRM group developed minor early complications. One presented acute bleeding 12 hours after the procedure, which we examined with an anoscope without anesthesia. The bleeding stopped spontaneously. Another developed a submucosal hematoma 72 hours after the procedure, which was resolved by means of a small incision for drainage under local anesthesia. The frequency of late complications was similar for the two groups. There was one case of anal incontinence (Grade 2) and urgency in a 38 year-old patient of the CH group. This patients endoanal ultrasound showed a complete internal anal sphincter and an anterior defect in the external anal sphincter, probably caused by an obstetrical trauma. Another 47-year-

old female SRM patient experienced dyspareunia from the third week through the seventh week after the procedure. No inclusion of the vaginal mucosa was found. There were three cases of anal pruritus, one in the SRM and two in the CH group. All were mild and associated with perianal moisture. One of the CH patients who experienced anal pruritus was also the patient who experienced urgency and anal incontinence. One patient in each group presented mild anal stricture. Both responded successfully to medical treatment (Table 2). Two months after the procedure, the surgical wounds of all SRM patients and 90.2 percent of CH patients had healed, and a similar number of patients in the two groups had presented bleeding. Anal pruritus and pain were more frequent in the CH patients but statistically nonsignificant. At last follow-up, the number of asymptomatic CH patients increased significantly between two months after the procedure and the last follow-up (68.3 percent after two months vs. 85.4 percent at last follow-up; P 0.016). Also, the number of asymptomatic patients was practically the same for both SRM and CH groups at last follow-up. Ninetysix percent of SRM patients experienced some improvement in bleeding, and total remission was achieved in 81.5 percent of the cases, compared with 95.1 percent of CH patients (P 0.043). Anal pruritus was experienced by four CH patients. Of these, two were present before surgery, and three cases were mild and associated with perianal moisture. One case, which did not improve with surgery, was diagnosed as idiopathic and treated with standard measures and anxiolytic drugs. There were no cases of anal pain associated with thrombosis. There were two cases of mild and episodic anal pain in SRM patients. One was associated with recurrent partial prolapse and the other with an increase in the consistency and diameter of stools in a patient with mild postsurgical stricture. Two CH patients also experienced mild episodic anal pain or discomfort. One presented anal incontinence and the other mild stricture after the procedure. Anal discomfort was not modified in one CH patient with preoperative anal incontinence (Table 3). Only one recurrence was found, in a 56-year-old male SRM patient with Grade IV HD. This patient experienced a partial prolapse (confined to only one hemorrhoidal pack), anal pain and pruritus, and bleeding similar to the bleeding before the procedure.

1372

CORREA-ROVELO ET AL

Dis Colon Rectum, October 2002

It was successfully treated by fastening the prolapsed hemorrhoids with elastic bands. Patient satisfaction was statistically the same two months after the procedure and during the last follow-up in the two groups. Three patients of the SRM group and two of the CH group reported poor satisfaction because of persistent tags in the first group and discomfort or anal pain in the second one. A significantly higher number of SRM patients stated they would be willing to undergo the same procedure (Table 3).

DISCUSSION
This study shows that both stapled rectal mucosectomy and closed hemorrhoidectomy are safe as a surgical treatment for patients with uncomplicated Grade III and IV hemorrhoidal disease. CH was superior for bleeding control in Grade III and IV hemorrhoidal disease, but more painful and disabling than SRM. In accordance with previous observations, our results with a large group of patients with at least a six-month follow-up indicate that SRM is performed faster, causes less postoperative pain, requires less intake of analgesics, allows bowel movement to be resumed sooner, and reduces the length of disability.1214 SRM has gradually been gaining acceptance among surgical groups in Europe, and recently in Asia and America.8,1214 Its postoperative period is considered less painful and less disabling than conventional open or closed hemorrhoidectomy, both of which have been shown to be equally painful.1214,19 The information about the efficiency and safety of this new technique is based on reports of case series8 and comparisons with conventional techniques in the short-term. Two published studies include a series of 40 patients12,13 and another has been reported with 119 patients but a follow-up of three months.14 The decrease in postoperative pain in SRM is apparently a result of less trauma to the innervation of the anal canal, because free nerve endings located in the transitional area are closer to the anal valves.10,11 Because of the variable length of the transitional zone, a portion may have to be resected to reposition the hemorrhoids adequately by SRM, as happened in one-half of our patients. This does not mean that a subtotal hemorrhoidectomy must be performed. The inclusion of squamous epithelium must be avoided so that postoperative pain from SRM is less than that of a conventional hemorrhoidectomy. As the pain experienced by patients may be influenced by the level of staplingat least in some

cases15the clinical response in the long run can be correlated with the level of stapling. In our study the level of stapling on average was 28.9 mm. Some clinical trials do not mention the level of stapling1215 or the type of epithelium found.12,13,15 Longo20 believes that in some of these patients with pain, a subtotal hemorrhoidectomy with the stapler is performed instead of a hemorrhoid-preserving mucosectomy. This is important, because if the pursestring suture is placed 2 to 3 cm over the dentate line, perhaps part of the hemorrhoid is being included. In addition, it may be seen as anoderm in the histologic examination, as happened in three of the patients we operated on before this clinical trial. The percentage of early complications for the CH group was not significantly greater than that of the SRM group and all early complications were considered minor. Late complications in the two groups were similar. Contrary to that reported by Cheetham,15 none of our patients developed chronic and disabling anal pain caused by the SRM procedure. We cannot currently find a clear explanation for this discrepancy. Only 6 of 42 of our SRM patients took analgesics for more than 7 days for anal pain, and the longest time analgesics were used was 15 days. A female patient developed dyspareunia that lasted four weeks and remitted spontaneously. This could be attributed to the inclusion of rectovaginal septum, because no other clear source was found. Other authors have reported that up to 8 percent of female patients experienced dyspareunia after coloanal or ileoanal anastomoses performed with a circular stapler.21 Our SRM patients did not present prolonged fecal urgency, contrary to that reported in another study.15 Some patients in both groups developed minor and temporary changes in continence during the first postoperative days, which we believe were part of an adaptation period perhaps because of transitory damage of anal sensitivity. Only one SRM patient and three CH patients experienced minor anal incontinence two months after the procedure. Anal incontinence persisted at further follow-up in two of the CH patients. One of these patients had previous damage to the external anal sphincter. SRM patients experienced no change in continence, despite similar findings of smooth muscle fibers in specimens from the two groups. Damages to the internal sphincter as diagnosed by endoanal ultrasound are rare and not necessarily associated with incontinence.8,14,15 Unlike other reports, none of our patients experienced fever 48 hours after the procedure, and no pelvic sepsis was found in either group.22 Our findings regarding clinical response at two months are similar to those reported by Ho at six

Vol. 45, No. 10

STAPLED RECTAL MUCOSECTOMY

1373

weeks.14 At Month 3 Ho reports a 1.8-percent incidence of minor bleeding from the wound, but there are no longer-term results. Although no significant difference in percentage of healing was found between the two techniques, bleeding control was higher for CH. According to a long-term report on closed hemorrhoidectomy by the Ferguson Clinic, 7.4 percent of 1,016 patients that were followed up during 5 years experienced some bleeding, and only 0.15 percent required surgical treatment because of additional hemorrhoidal tissue.23 McConnel reported that 2.5 percent of 441 patients followed up 1 to 7 years experienced some bleeding, and 7.5 percent required some treatment because of a residual hemorrhoidal problem.24 According to a report by Longo, 23.8 percent of 101 patients with bleeding treated by SRM and followed up during at least one year experienced bleeding, of which 2.9 percent showed no improvement and 0.6 percent a partial recurrence.8 Thus a difference in the control of bleeding may be expected in the long term. The permanence of hemorrhoids even in cases of regression may predispose patients, whose prolapse has been corrected, to experience minor bleeding originating in capillaries of the lamina propria.9,25 Despite the clinical response, there was no difference in patient satisfaction between the groups. Nevertheless, a significantly higher number of SRM patients were willing to undergo the same procedure. We believe this is secondary to a more prolonged and disabling postoperative period caused by CH. The main cause of poor satisfaction within the SRM group was not bleeding, but rather the lack of regression of the external component. Thus, patients with a significant external component may benefit more from another technique. Although a cost analysis was not considered in this research, we believe the use of the stapler in the SRM procedure increases the cost of the surgery. This is probably balanced by the cost associated with the disability caused by CH, although we did not analyze this.

formed is a subtotal hemorrhoidectomy or a mucosectomy with hemorrhoidal packs repositioning.

ACKNOWLEDGMENT
The authors thank Carla Archer-Dubon, M.D., for translation and revision of the manuscript.

REFERENCES
1. Hass PA, Hass GP, Schmaltz S, Fox TA. The prevalence of hemorrhoids. Dis Colon Rectum 1983;26:4359. 2. Gazet JC, Redding W, Rickett JW. The prevalence of haemorrhoids. A preliminary survey. Proc R Soc Med 1970;63(Suppl):78 80. 3. MacRae HM, McLeod RS. Comparison of hemorrhoidal treatments: a meta-analysis. Can J Surg 1997;40:14 7. 4. Mathai V, Ong BC, Ho YH. Randomized controlled trial of lateral internal sphincterotomy with haemorrhoidectomy. Br J Surg 1996;83:380 2. 5. The Standards Task Force American Society of Colon and Rectal Surgeons. Practice parameters for the treatment of hemorrhoids. Dis Colon Rectum 1993;36:1118 20. 6. Bassi R, Bergami G. The surgical treatment of hemorrhoids: diathermocoagulation and traditional techniques. A prospective randomized study. Minerva Chir 1997;52:3879. 7. Longo A. Treatment of hemorrhoidal disease by reduction of mucosa and hemorrhoidal prolapse with a circular suturing device: a new procedure. Proceedings of the 6th World Congress of Endoscopic Surgery. Rome, 1998: 77790. 8. Pescatori M, Favetta U, Dedola S, Orosini S. Transanal stapled excision of rectal mucosa prolapse. Tech Coloproctol 1997;1:96 8. 9. Thomson WH. The nature of haemorrhoids. Br J Surg 1975;62:54252. 10. Fenger C. Histology of the anal canal. Am J Surg Pathol 1988;12:4155. 11. Duthie HL, Gairns FW. Sensory nerve endings and sensation in the anal canal region of man. Br J Surg 1960;47: 58595. 12. Mehigan BJ, Monson JR, Hartley JE. Stapling procedure for haemorrhoids versus Milligan-Morgan haemorrhoidectomy: randomised control trial. Lancet 2000;355:7825. 13. Khalil KH, OBichere A, Srllu D. Randomized clinical trial of sutured versus stapled closed haemorrhoidectomy. Br J Surg 2000;87:13525. 14. Ho YH, Cheong WK, Tsang C, et al. Stapled hemorrhoidectomy cost and effectiveness. Randomized, controlled trial including incontinence scoring, anorectal manometry, and endoanal ultrasound assessments at up to three months. Dis Colon Rectum 2000;43:1666 75. 15. Cheetham MJ, Mortensen NJ, Nystrom PO, et al. Persis-

CONCLUSION
Our results suggest that both stapled rectal mucosectomy and closed hemorrhoidectomy are safe procedures. Their clinical advantages are different, because CH is superior for bleeding control in Grade III and IV hemorrhoidal disease but more painful and disabling than SRM. We consider further long-term follow-up studies are needed; also, to facilitate a future metaanalysis, studies should specify whether the surgery per-

1374

CORREA-ROVELO ET AL

Dis Colon Rectum, October 2002

16. 17. 18.

19.

20. 21. 22. 23.

24.

25.

tent pain and fecal urgency after stapled haemorrhoidectomy. Lancet 2000;356:730 3. Fazio VW. Early promise of stapling technique for haemorrhoidectomy. Lancet 2000;355:768 9. Ferguson JA, Mazier WP, Ganchrow MI, et al. The closed technique of hemorrhoidectomy. Surgery 1971;70:480 4. Browning GG, Parks AG. Postanal repair for neuropathic faecal incontinence: correlation of clinical result and anal canal pressures. Br J Surg 1983;70:101 4. Ho YH, Seow-Choen F, Tan M, et al. Randomized controlled trial of open and closed haemorrhoidectomy. Br J Surg 1997;84:1729 30. Longo A. Pain after stapled haemorrhoidectomy. Lancet 2000;356:2189 90. Keighley MR, Grobler S, Bain I. An audit of restorative proctocolectomy. Gut 1993;34:680 4. Molloy RG, Kingsmore D. Life threatening pelvic sepsis after stapled haemorrhoidectomy. Lancet 2000;355:810. Ganchrow MI, Mazier WP, Friend WG, Ferguson JA. Hemorrhoidectomy revisiteda computer analysis of 2,038 cases. Dis Colon Rectum 1971;14:128 33. McConnell JC, Khubchandani IT. Long-term follow-up of closed hemorrhoidectomy. Dis Colon Rectum 1983;26: 7979. Loder PB, Kamm MA, Nicholls RJ, Phillips KS. Haemorrhoids: pathology, pathophysiology and aetiology. Br J Surg 1994;81:946 54.

Invited Commentary
To the EditorThe optimal management of the ubiquitous pile or hemorrhoid is a subject which is, of necessity, close to the heart of most colorectal surgeons worldwide. The conventional management of first and second degree hemorrhoids involves attention to bowel habit and avoidance of straining. A variety of nonsurgical interventions have also been described including injection sclerotherapy, rubber band ligation, infrared coagulation and cryotherapy the latter being of largely historical interest. Each and every proctologist ranks each of these techniques differently in his or her armamentarium for the treatment of hemorrhoidal disease. The optimum treatment of third and fourth degree hemorrhoids is surgical excision although the means by which this is undertaken also varies widely. Stapled hemorrhoidectomy was presented as a new technique for the treatment of prolapsing hemorrhoids by Antonio Longo in 1998.1 The technique represents the first radical re-think of our management of hemorrhoids in many years. This procedure uses an intraluminal circular stapling gun to excise a circumferential ring of mucosa from above the hem-

orrhoidal cushions. The procedure aims to restore anorectal anatomy by returning the hemorrhoidal cushions to the anal canal, and therefore differs radically in its goals from conventional excisional hemorrhoidectomy. Although initially introduced in southern Europe in a relatively uncontrolled fashion, this technique has now been subjected to assessment by several rigorous randomized controlled trials. Though small these trials are remarkably consistent in their findings.25 They conclude that stapled hemorrhoidectomy is a quick and safe procedure which appears to be easy to learn. The procedure is not pain free but does appear to be associated with significantly less pain than formal hemorrhoidectomy. This is to be anticipated since there is no significant disruption of the sensitive anoderm. All of these trials are deficient in long-term follow-up, but indicate that the technique holds promise and may come to play a significant role in future proctologic practice. The current study is sound in planning and execution and represents an important addition to the existing body of evidence. Such well conducted randomized, controlled trials in coloproctology are to be welcomed. Stapled hemorrhoidectomy was found to take significantly less time than conventional hemorrhoidectomy. In addition, mean and maximum postoperative pain levels, analgesic requirements, time to first bowel movement and length of disability were all found to be significantly shorter after the stapled procedure. The incidence of early complications at 7.1 percent was lower than that following conventional hemorrhoidectomy (21.4 percent), although the incidence of individual complications such as urinary retention and bleeding was so low as to prevent meaningful comparison between the two groups. Late complications such as anal stricture and anal incontinence were in fact notably infrequent in both treatment arms. So what does this admirable effort tell us about this new procedure? It must be said that much of the above has already been shown in comparable studies. However, the ability to reproduce the findings of clinical trials around the world is reassuring. One of the major points of concern with regard to this procedure was raised by the St. Marks group.6 This group abandoned a randomized controlled trial prematurely because at 6 month follow up 6 of 16 patients followed to this time had distressing symptoms of rectal pain and faecal urgency. These symptoms persisted for up to and beyond fifteen months. Independent review by proctologists failed to identify any

Vol. 45, No. 10

STAPLED RECTAL MUCOSECTOMY

1375

apparent cause for this constellation of symptoms. No group has before or since reported difficulties of this nature. This study has reported no such phenomena although two patients in the stapled group reported mild and episodic anal pain. These data are reassuring and it remains to be explained why large numbers of these cases have now been performed without the distressing and disabling complications seen in the St. Marks experience. This article thus adds to the growing evidence base to suggest that stapled hemorrhoidectomy can be performed safely and with advantages for postoperative recovery. Immediate complications given appropriate training and mentorship also seem unlikely to be a significant problem. The issue which remains to be settled is the long term efficacy of the technique. If a pursestring is placed accurately at an appropriate height above the dentate line the stapler can be fired to excise a ring of mucosa with apparently minimal discomfort for the patient. However where does this procedure rank in terms of control of hemorrhoidal symptoms? Unfortunately, the follow-up in the current study was short. All patients were followed for six months, but only two thirds of each arm were followed for longer and none for more than fourteen months. As the authors suggest, their data on symptom control and patients satisfaction out to this point are reassuring. However the durability of the approach cannot be adequately assessed at this time. Finally, perhaps the major concern in the minds of the unconvinced or downright sceptical lies in the issue of whether the excision of a ring of mucosa above the anal canal can adequately deal with the external hemorrhoidal component. This, afterall, is the indication for surgical treatment of hemorrhoids. This study really takes us no further in this regard. We are told that there was no difference in patient satisfaction between the two arms of the study to the limit of follow-up. However, the major source of dissatisfaction following the stapled procedure was failure of regression of the external component. Unfortunately

we are given no data as to the incidence of skin tags at the duration of follow up and the requirement for further intervention. In conclusion, therefore, the authors are to be congratulated on a well-conducted study. However, the evaluation of stapled hemorrhoidectomy remains some way short of completion. We need to see longer-term follow-up from these early studies, particularly with regard to success or failure in the management of the external component, before this technique can be wholeheartedly embraced.

REFERENCES
1. Longo A. Treatment of haemorrhoid disease by reduction in mucosal and haemorhoidal products with a circular stapling devicenew procedure. Proceedings of the 6th World Congress of Endoscopic Surgery. Rome, Italy, June 3 to 6, 1998. 2. Mehigan BJ, Monson JR, Hartley JE. Stapling procedure for haemorrhoids versus Milligan Morgan haemorrhoidectomy: a randomised controlled trial. Lancet 2000;355:7825. 3. Roswell M, Bello M, Hemingway DM. Circumferential mucosectomy (stapled haemorrhoidectomy) versus conventional haemorrhoidectomy: a randomised controlled trial. Lancet 2000;355:78199. 4. Ho YH, Cheong WK, Tsang C, et al. Stapled hemorrhoidectomy cost and effectiveness. Randomized, controlled trial including incontinence scoring, anorectal manometry, and endoanal ultrasound assessments up to three months. Dis Colon Rectum 2000;43:1666 75. 5. Ganio E, Altomare DF, Gabrielli F, Milito G, Canuti S. Prospective randomised multicentre trial comparing stapled with open haemorrhoidectomy. Br J Surg 2001;88: 669 74. 6. Cheetham MJ, Mortenson N, Nystrom PO, Kamm MA, Phillips RK. Persistent pain and faecal urgency after stapled haemorrhoidectomy. Lancet 2000;356:730 3.

John Hartley, M.D. Hull, United Kingdom [Editors NoteThe authors decline to respond to the commentary.]