Treatment of Hemorrhoids with Circular Stapler, a New Alternative to Conventional Methods: A Prospective Study of 140 Patients

Treatment of Hemorrhoids with Circular Stapler, a New Alternative to Conventional Methods: A Prospective Study of 140 Patients Jean-Pierre Arnaud, MD, Patrick Pessaux, MD, Noel Huten, MD, Nicolo De Manzini, MD, Jean-Jacques Tuech, MD, Berangere Laurent, MD, Michele Simone, MD BACKGROUND: STUDY DESIGN: RESULTS: CONCLUSIONS: Surgical hemorrhoidectomy has a reputation for being a painful procedure. The aim of this study was to determine the efficacy and safety of a new procedure for surgical treatment of hemorrhoid disease. From April 1998 to August 1998, 140 patients (83 men and 57 women) with an average age of 43.8 years (range 19 to 83 years) underwent hemorrhoidectomy using a circular stapler. Operative times, peri- and postoperative complications, mean hospital stay, assessment of the postoperative pain, period of incapacity for work, and functional results were collected. All patients were evaluated at 2 weeks, 2 months, and 18 months after operation. The average length of the operation was 18 minutes (range 8 to 60 minutes). There were no perioperative complications. The postoperative complication rate was 6.4% (n 9). Mean hospital stay was 36 hours (range 8 to 72 hours). Paracetamol was the only analgesic used. Eighty-three patients (59.3%) required analgesic for less than 2 days, 45 patients (32.1%) between 2 and 7 days, and 12 patients (8.6%) more than 7 days. No patients had anal wound care. One hundred four patients had professions. The period of incapacity for work was less than 3 days for 22 patients (21.1%), between 3 and 7 days for 13 patients (12.5%), between 7 and 14 days for 62 patients (59.6%), and more than 14 days for 7 patients (6.8%). At 18 months, 95.7% of patients were fully satisfied with the results, 3.6% were somewhat satisfied (n 4), and 0.7% were unsatisfied. Treatment of hemorrhoids with a circular stapler appears to be safe, effective, and rapid, causing few postoperative complications and minimal postoperative pain. At 18 months, 95.7% of the patients were fully satisfied with the results. (J Am Coll Surg 2001;193:161 165. 2001 by the American College of Surgeons) No competing interests declared. Received September 6, 2000; Revised January 17, 2001; Accepted March 6, 2001. From the Departments of Visceral Surgery, CHU Angers, Angers (Arnaud, Pessaux, Tuech); CHU Hopital Trousseau, Tours (Huten, Laurent); and CHU Hopital Hautepierre, Strasbourg (De Manzini, Simone); France. Correspondence address: Jean-Pierre Arnaud, MD, CHU Angers - Department of Visceral Surgery, 4 Rue Larrey, 49033 Angers Cédex 01, France. The results of various techniques of hemorrhoidectomy have been reported 1-3 in an attempt to find the ideal operation with low morbidity and good functional and clinical results. Open hemorrhoidectomy, as described by Milligan and associates in 1937, 4 has been accepted worldwide as the best choice for treatment of symptomatic hemorrhoids. Although this technique is safe and effective, it is associated with postoperative pain, occasional long hospitalization, and requirement of local care, and stricture may ensue. Longo 5 originally described a new surgical technique for treatment of hemorrhoid disease using a circular stapler normally used for low rectal anastomosis. There are only three prospective randomized studies demonstrating significant advantages of this technique for patients compared with conventional hemorrhoidectomy. But there weren t many patients, and longer-term efficacy remains unknown. 6-8 The aim of this large study was to determine the efficacy and the safety of this new procedure with a longterm followup. 2001 by the American College of Surgeons ISSN 1072-7515/01/$21.00 Published by Elsevier Science Inc. 161 PII S1072-7515(01)00973-5

162 Arnaud et al Treatment of Hemorrhoids with Circular Stapler J Am Coll Surg Figure 1. At the distance of 4 5 cm from the dentate line, one purse string was prepared in the rectal mucosa and submucosa with 00 monofilament. (From Ethicon Endo-Surgery, Issy les Moulineaux, France, with permission) METHODS Techniques The procedure can be carried out under local or regional anesthesia. Antibiotic prophylaxis with a single dose of methronidazole was given preoperatively. Patients were placed in Lloyd-David position. An anal retractor was used. The dentate line was easily identified. Starting from the anterior rectal wall at the distance of 4 to 5 cm from the dentate line, the longitudinal folds of mucosa were raised clockwise in succession and pierced at the base with 00 monofilament (Fig. 1). In such a way, a purse-string suture was carried out, including only the mucous and submucous membrane, through the entire circumference of the distal portion of the rectal ampulla. An Ethicon Endo-Surgery SDH 33 circular stapler (Ethicon Endo-Surgery, Issy les Moulineaux, France) in its maximum open position was inserted into the rectum so that the head passed the purse string (Fig. 2). The purse-string was tied around the stapler shaft. The stapler device was closed slowly and tightly. In women the posterior vaginal wall was checked before firing the stapler to prevent its entrapment. The stapler was then fired and gently withdrawn. The excised tissue was checked. Figure 2. The head of the circular stapler is opened and placed into the anus behind the mucosal purse string. (From Ethicon Endo- Surgery, Issy les Moulineaux, France, with permission) This had the appearance of a soft cylinder, 3 to 4 cm in height, contained only mucous and submucous membrane, and hemorrhoids. After the stapler was extracted, a circular suture at least 2 cm above the dentate line could be observed. If the suture bled, a complementary homeostasis could be carried out with an infiltration of adrenaline solution or with a stitch with 000 monofilament. A Foley catheter was positioned and if, after 3 hours, there was no suspicion of bleeding, removed. The mucosal rings were histologically examined to exclude any entrapment of rectoanal muscle fibers. Oral laxatives were prescribed for at least 2 weeks postoperatively to prevent excessive straining. PATIENTS From April 1998 to August 1998, 140 patients (83 men and 57 women) with an average age of 43.8 years (range 19 to 83 years) underwent correction of hemorrhoids using a circular stapler in three university hospital centers. The degree of hemorrhoids has been classified: 3 cases of degree II, 97 cases of degree III, and 40 cases of degree IV. Thirty-eight patients had associated skin tags.

Vol. 193, No. 2, August 2001 Arnaud et al Treatment of Hemorrhoids with Circular Stapler 163 Patients complained preoperatively of many symptoms that were present for more than 1 year (range 1 to 6 years): anal discomfort in 140 patients (100%), bleeding in 110 patients (78.5%), wet anus in 16 patients (11.4%), and itching in 20 patients (14.3%). An earlier treatment was offered to 15 patients (10.7%): 8 cases of rubber band ligation and 7 cases of sclerotherapy. All patients had dietary measures. Preoperative investigations included a full proctologic visit with anuscopy. All the patients were evaluated at 2 weeks, 2 months, and 18 months after the operation. Statistical analysis The Mann-Whitney U test was used to establish the difference between preoperative and postoperative resting and squeeze anal pressure. RESULTS The average length of the operation was 18 minutes (range 8 to 60 minutes). There were no perioperative complications, but because of bleeding, the staple lines required suture reinforcement in 15 patients and an infiltration of adrenaline solution in 2 patients. The postoperative complication rate was 6.4% (n 9): there were five cases of bleeding in the 12 postoperative hours, two of which necessitated homeostasis with general anesthesia, two cases of urinary retention, and two cases of external hemorrhoid thrombosis. Mean hospital stay was 36 hours (range 8 to 72 hours). There were five patients in ambulatory surgery. We used only paracetamol. Patients assessed their pain in the 5 days after the operation on a visual analogue scale (VAS) ranging from 0 to 10. One hundred thirteen patients (80.7%) noted values ranging between 0 and 3. The pain at the first defecation was assessed on a VAS ranging between 1 and 3. Eighty-three patients (59.3%) required analgesic for less than 2 days, 45 (32.1%) patients between 2 and 7 days, and 12 patients (8.6%) for more than 7 days. No patients had anal wound care. One hundred four patients had a professional activity. The period of the patients incapacity for work was less than 3 days for 22 patients (21.1%), between 3 and 7 days for 13 patients (12.5%), between 7 and 14 days for 62 patients (59.6%), and more than 14 days for 7 patients (6.8%). All resected rings were examined histologically: three contained some smooth muscular fibers and three contained incomplete tissues. The mean distance between the circular suture and the dentate line, verified at anoscopy, about 2 months after operation was 2.2 cm (range 1.5 to 3 cm). Symptoms were completely eliminated in all patients except one. Two patients presented a submucosal hematoma on day 21 after operation. Five patients presented a moderate stricture, diaphragm-like and easily dilated on digital examination. These patients were interviewed: none presented functional trouble (no pain, no fecal urgency, and no anal burning sensation or anal discomfort). Three had muscular fibers in the resected specimen. Two patients complained of persistent skin tags. In these patients the string suture was placed too high: 3 cm above the dentate line. Only 86 patients (61.5%) underwent preoperative manometry, and it was performed in 112 patients (80%) during postoperative assessments. Mean resting pressure was 61 mmhg (range 43 to 111 mmhg) before and 59 mmhg (range 20 to 223 mmhg) after operation (p 0.05). Mean squeeze pressure was 139 mmhg (range 90 to 229 mmhg) before and 143 mmhg (range 84 to 189 mmhg) after operation (p 0.05). At 18 months, 95.7% of the patients were fully satisfied with the results, 3.6% were somewhat satisfied (n 4), and 0.7% (n 1) were unsatisfied (persistence of hemorrhoid). DISCUSSION Treatment of hemorrhoids requires caution because of the difficulty in controlling bleeding and because of the postoperative pain. Intensive analgesic has often been prescribed. With this new technique, paracetamol was the only analgesic used. Few studies have reported the results of this new procedure. 6-14 To date, only three single-center randomized trials of, respectively, 22, 42, and 119 patients have been published. 6-8 (Table 1) The control arm underwent standardized diathermy excision hemorrhoidectomy. Trials in the UK 6,7 used an analogue pain score scale and confirmed that postoperative pain was significantly lower after the stapled technique. Ho and associates 8 showed that maximal pain in the hospital and 2 weeks after operation, and pain at evacuation of stool while in the hospital and 2 weeks after operation, were significantly less after stapled compared with diathermy hemorrhoidectomy. Results of mean operative times were contradictory. Anesthesia time was significantly shorter in the stapled group for Mehigan and colleagues, 7 but for Ho and coworkers 8 the diathermy hemorrhoidectomy was quicker to perform. Another objective of cost effectiveness is to reduce the postoperative hospital stay and the lost work time. Rowsell and

164 Arnaud et al Treatment of Hemorrhoids with Circular Stapler J Am Coll Surg Table 1. Results of the Prospective Randomized Trials Rowsell et al 6 Mehigan et al 7 Ho et al 8 Variables SH DH p Value SH DH p Value SH DH p Value n 11 11 20 20 57 62 Hemorrhoids Grade 3 Grade 3 or 4 Grade 4 Mean operative time (min) 18 22 0.007 17.6 11.4 Mean pain score 20.64 44.27 0.003 2.1 6.5 0.0001 Return to normal activities (d) 8.1 16.9 0.005 17 34 0.0002 17.1 22.9 0.05 Satisfaction at 3 mo 85%* 75%* 0.05 8.6 8.2 0.05 * % of patients with good or excellent satisfaction. Score range was 0 (complete dissatisfaction) to 10 (fully satisfied). DH, diathermy hemorrhoidectomy; SH, stapled hemorrhoidectomy. associates 6 found a shorter hospital stay for the stapled group, but Mehigan and colleagues found no significant difference (60% of the stapled group and 75% of the diathermy group were discharged within 24 hours). Each trial confirmed the reduction in lost work time after stapled hemorrhoidectomy. Neither of the UK trials 6,7 reported any major complications. Ho and coworkers 8 showed similar total complication rates from stapled and diathermy hemorrhoidectomy (18% and 26%, respectively). Ho and associates 8 study was different from the others in that manometry and ultrasonography were performed before and after operation and an incontinence score was used. Minor incontinence occured postoperatively in two patients in both groups. Changes between preoperative and postoperative anorectal manometry were similar in the two groups. At 3 months after operation, a quality of life questionnaire showed no significant difference between the two groups (mean score: 126.4 versus 120). But the mean total related medical costs incurred over the 3-month period were significantly less in diathermy hemorrhoidectomy ($921.17) than in stapled hemorrhoidectomy ($1,283.09). The cause of hemorrhoids is still debated. Theories have included venous varicosities of the anus, vascular hyperplasia in the hemorrhoidal vascular tissue, and a mucosal prolapse of the anal canal mucosa resulting in elongation and kinking of the upper and middle hemorrhoidal vessels. This new procedure does not excise hemorrhoidal tissue at the anus, but consists of an excision of a circumferential column of mucosa and submucosa immediately above the hemorrhoids, and then a stapling of the defect. The prolapsed hemorrhoidal tissue is drawn back into a physiologic position within the anal canal. The blood supply to the hemorrhoidal tissue is interrupted by excision and stapling of the submucosal layer in which these vessels run. Using a circular stapler to resect the mucous membrane has an advantage: before being resectioned, the mucous membrane is sutured by clips, avoiding contamination of the submucosal space. But a severe pelvic sepsis after stapled hemorrhoidectomy was reported. 15 The pathophysiology was unclear. A possibility is that the firing of the stapler enabled gas-producing organisms in the rectal lumen to enter the pararectal space. The procedure is easy to perform, takes only about 15 minutes, and induces few and minor postoperative complications. The important concern is the resection of the mucosal membrane. Histologic examination of the resected specimens should not show any muscular fibers. They had been present in three patients without damage to the sphincter mechanism, but there was a risk of stricture. Although the cost of the stapler device is still relatively high, hospital stay and the period of the patient s incapacity for work are short. The total cost to the community is important. The absence of local care and less postoperative pain are clear advantages to the patient. Stapled hemorrhoidectomy does not involve dissection and excision of the perianal skin, and this undoubtedly contributes to reduced pain scores. Carrying out a mucomucous anastomosis 4 to 5 cm from the dentate line, in a region with few sensory receptors and mucous somatic fibers, sets the theoretic premises for surgery involving a low level of postoperative pain. At 18 months, 95.7% of the patients were fully satisfied with the results. Some complications have been reported. 16 In fact in a recent study, 17 the results were less satisfactory: 5 of 16 patients (31%) developed symptoms of pain and fecal

Vol. 193, No. 2, August 2001 Arnaud et al Treatment of Hemorrhoids with Circular Stapler 165 urgency that persisted for up to 15 months postoperatively. The randomized trial was suspended. The mechanism behind this phenomenon is unclear, although muscle incorporation in the ring may have a role. A suggested prophylactic technique is submucosal injection of saline at the planned site of the purse-string suture, to reduce the risk of incorporation of rectal muscularis propria into the stapler housing. In conclusion, treatment of hemorrhoids with a circular stapler appears to be safe, effective, and rapid, bringing about few postoperative complications and little postoperative pain. At 18 months, 95.7% of the patients were fully satisfied with the results. The benefits of the new method, which have already been proved in three randomized trials, 6-8 were found in this study in large populations with longterm followup. A multicentric, randomized, prospective study including a large number of patients is in progress to compare this new alternative procedure with conventional methods. REFERENCES 1. Boccasanta P, Zennaro F, Maione O, Salamina G. Emorroidectomia secondo la tecnica dell Hopital L Bellan: Risultati e complicanze in 50 casi. Oris Med 1992;6:20 22. 2. Dodi G, Pacchioni A, Oblak JK, Lise M. Hemorroidectomy according to the St. Marks s Hospital technique. Atti Second World Week of Professional Updating in Surgery and Surgical and Oncological Disciplines of the University of Milan. 1990; 3:1232 1234. 3. Alexander-Williams J. The management of piles. BMJ 1982; 285:1137 1139. 4. Milligan ETC, Morgan CN, Jones LE, Officier R. Surgical anatomy of the anal canal and the operative treatment of hemorroids. Lancet 1973;1:119 124. 5. 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, 1998. Rome: Mundozzi Editor; 1998: 777 784. 6. Rowsell M, Bello M, Hemingway DM. Circumferential mucosectomy (stapled haemrrhoidectomy) versus conventional haemorrhoidectomy: randomised controlled trial. Lancet 2000; 355:779 781. 7. Mehigan BJ, Monson JRT, Hartley JE. Stapling procedure for haemorrhoids versus Milligan-Morgan haemorrhoidectomy: randomised controlled trial. Lancet 2000;355:782 785. 8. Ho YH, Cheong WK, Tsang C, et al. Stapled hemorrhoidectomy Cost and 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. 9. Kohlstadt CM, Weber J, Prohm P. Stapler hemorrhoidectomy. A new alternative to conventional methods. Zentralbl Chir 1999;124:238 243. 10. Roveran A, Susa A, Patergnani M. Hemorrhoidectomy with circular stapler in advanced hemorrhoid pathology. G Chir 1998;19:239 240. 11. Allegra G. Experiences with mechanical staplers: hemorrhoidectomy using circular stapler. G Chir 1990;11:95 97. 12. Gravie JF. Traitement des hémorrhoïdes de stade III et IV par la technique de Longo. Ann Chir 1999;53:245 247. 13. Papillon M, Arnaud JP, Descottes B, et al. Le traitement de la maladie hémorroïdaire par la technique de Longo. Résultats préliminaires d une étude prospective portant sur 94 cas. Chirurgie 1999;124:666 669. 14. Beattie GC, Lam JPH, Loudon MA. A prospective evaluation of the introduction of circumferential stapled anoplasty in the management of haemorrhoids and mucosal prolapse. Colorectal Disease 1999;2:137 142. 15. Molloy RG, Kingsmore D. Life threatening pelvic sepsis after stapled haemorrhoidectomy. Lancet 2000;355:810. 16. Fazio VW. Early promise of the stapling technique for haemorrhoidectomy. Lancet 2000;355:768 769. 17. Cheetham MJ, Mortensen NJM, Nystrom PO, et al. Persistent pain and faecal urgency after stapled haemorrhoidectomy. Lancet 2000;356:730 733.