Prospective, Randomized Study: Proximate PPH Stapler vs. LigaSure for Hemorrhoidal Surgery

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1 Prospective, Randomized Study: Proximate PPH vs. LigaSure for Hemorrhoidal Surgery Matthias Kraemer, M.D., 1 Tengis Parulava, M.D., 2 Michael Roblick, M.D., 1 Lothar Duschka, M.D., 2 Heinrich Müller-Lobeck, M.D. 2 1 Department of General Surgery/Coloproctology, St. Barbara-Klinik, Hamm-Heessen, Germany 2 Department of Surgery/Coloproctology, Deutsche Klinik für Diagnostik, Wiesbaden, Germany PURPOSE: It has been shown that for hemorrhoidal surgery both LigaSure and stapler cause less pain than diathermy or scissor dissection. This study has attempted to establish which of the less painful alternatives proves best in an unselected series of patients with hemorrhoidal disease. METHODS: Fifty patients were randomized to undergo stapling hemorrhoidopexy or LigaSure hemorrhoidectomy. Parameters investigated were pain (primary parameter), patient satisfaction with treatment, and recovery of personal activity. Other factors investigated were operative result, ease of handling, analgesic requirements, and postoperative course. RESULTS: Both methods were found to be equivalent in all major aspects analyzed. Postoperative pain scores (P = 0.99), patient satisfaction (P = 1), and self-assessment of activity (P = 0.99) were almost identical in both groups of patients. Significant differences were found in none of the numerous factors investigated. CONCLUSION: Both methods can be used safely and without major disadvantage for the patient regardless of stage and extent of hemorrhoidal disease. [Key words: Hemorrhoidal surgery; Technical handling; Patient recovery] Presented at the 31st Deutscher Koloproktologen-Kongress, München, Germany, March 17 to 20, Reprints are not available. Correspondence to: Matthias Kraemer, M.D., Abteilung Allgemeinchirurgie/Koloproktologie, St. Barbara-Klinik, Postfach 5140, 59041, Hamm, Germany, mkraemer@barbaraklinik.de Dis Colon Rectum 2005; 48: DOI: /s z The American Society of Colon and Rectal Surgeons Published online: 31 May 2005 C onventional hemorrhoidectomy is a widely practiced, well-established, and effective procedure. However, despite the relatively minor surgical trauma, the operation can be very painful 1,2 and convalescence may take six weeks or more. 3 This has stimulated continuing efforts to develop new techniques and modifications which promise a less painful course and faster recovery. A major new step in this direction has been the introduction of stapled hemorrhoidopexy. There are now several controlled studies confirming significantly less postoperative pain compared with conventional hemorrhoidectomy done with scissors or diathermy However, stapling does have certain limitations. If stapling is performed on patients with irreducible and prolapsed piles and/or extensive skin tags and other secondary findings, the procedure has to be supplemented by additional cutting or diathermy which limits the gain in pain reduction in such cases. 12 In addition, outside the setting of clinical studies, early recurrences are observed following the stapling technique. Other recently published controlled studies have shown that computer-guided bipolar diathermy (LigaSure, Tyco Healthcare, Gosport, UK) also causes less pain than if conventional diathermy is used for hemorrhoidal surgery A potential advantage of LigaSure lies in the fact that the operative technique is basically identical to conventional hemorrhoidectomy, only the means used for resection are different. Furthermore, the extent of resection is not limited by the amount of tissue fitting into the stapler head and patients with fourth-degree hemorrhoids or significant secondary findings can be operated on without having to resort to other means. 1517

2 1518 KRAEMER ET AL Dis Colon Rectum, August 2005 Table 1. Patient Characteristics Because both methods, stapler and LigaSure, have been shown to cause less pain than conventional hemorrhoidectomy, the issue of this study is to find out which method proves to be superior in an unselected series of patients with advanced hemorrhoidal disease, not only in terms of pain reduction, but also in terms of technical applicability and patient satisfaction. PATIENTS AND METHODS n Female Median age (range) 48 (28 82) 58 (40 71) Within the setting of a specialized coloproctologic department serving as supraregional referral center, a consecutive series of patients with symptomatic thirdand fourth-degree hemorrhoids were recruited for this study. The study was subject to ethics committee approval and a detailed written informed consent was obtained from all patients. Patients were randomized (by computer-generated block randomization) to undergo stapling hemorrhoidopexy (group 1, n = 25) or LigaSure hemorrhoidectomy (group 2, n = 25). A power test was performed; at least 20 patients were needed in each group to detect a difference of one standard deviation (SD) in mean pain score, with an 80 percent power at a 5 percent level of significance. For patient characteristics, refer to Table 1. Five patients (four of group 1, one of group 2) did not appear for their scheduled follow-up examination. All five patients lived farther than 50 km from the hospital. The patients and their referring doctors were contacted by telephone and told of an uneventful course without complications in all five instances. In accordance with the study protocol and for the sake of complete data acquisition, the five were excluded and five new cases were recruited (one by one in the order of exclusion). Preoperative assessment consisted of routine proctologic history and examination including proctoscopy and rigid sigmoidoscopy. The findings were recorded on a customized study form. There were no significant differences in the distribution of hemorrhoidal staging and associated findings Table 2. Hemorrhoidal Staging and Associated Findings Hemorrhoids: 2nd 3rd degree rd degree rd 4th degree 1 1 4th degree 2 0 Anal prolapse: partial complete 5 8 Skin tags 7 10 Fissures 3 0 Eczema 1 1 between both groups (Table 2). Patients were admitted to the hospital on the day of the operation and received a Fleet enema before the operation. The operations were performed under general (56 percent) or spinal (44 percent) anesthesia with the patients in the lithotomy position. All surgeons were experienced in hemorrhoidal surgery and familiar with both techniques; no teaching operations were performed. Stapling was done with the Proximate PPH stapler (Ethicon Endo-Surgery Inc., Cincinnati, OH) as described previously. In nine patients (36 percent) diathermy resection of residual prolapsing hemorrhoidal tissue or skin tags was added to the stapling procedure (Table 3). LigaSure hemorrhoidectomy was done using the Milligan Morgan technique. A small radial incision was made to define the internal sphincter; from there onward a longitudinal excision of the hemorrhoidal tissue was made along the subanodermal and submucosal planes. The tissue was sealed with LigaSure before cutting it, using the smaller 18-cm instrument. The operation was done in six patients (24 percent) with complete circular anal prolapse combined with segmental plastic reconstruction of the anal canal (Fansler-Arnold). This procedure consisted of dissection of trapezoid anodermal flaps from the anocutaneous junction upward. The flaps were then brought into the anal canal and anastomosed with the mucosa. Duration of the operation and intraoperative details were recorded on a questionnaire. The surgeon was asked to give an immediate assessment of the operative result (optimal, satisfactory, fair, unsatisfactory, unacceptable) and ease of handling (simple, slightly awkward, complicated). Routine postoperative analgesia consisted of metamizole ( drops) and diclofenac (3 50 mg) or ibuprofen (3 400 mg). Opiates were given only if required. Patients routinely received a bulking agent

3 Vol. 48, No. 8 STAPLER VS. LIGASURE FOR HEMORRHOIDS 1519 Table 3. Operative Procedures Classic Milligan Morgan 19 Additional procedures: Anodermal flap plasty 6 Classic stapler 16 Additional procedures: Segmental Milligan Morgan, skin tags 9 Table 4. Operating Time (min) Table 5. Assessment of Immediate Operative Result by Surgeon Overall 23/26 (10 80) 20/21 (6 54) Classic procedure 18/20 (10 37) 15/18 (6 40) Combined procedures 40/44 (20 80) 25/25 (15 54) Values are median/mean (range). P value = n % n % Optimal Satisfactory Fair Unsatisfactory 0 0 Unacceptable 0 0 P value = (Flosa). Analgesic requirements during the hospital stay, on discharge, and duration of analgesic therapy were recorded. Patients were asked to keep a diary from postoperative Day 1 to Day 21 and to daily record their intake of analgesic medication, the resumption of personal activity (0 100 percent), and any notable events. In addition, pain (primary end point) and satisfaction with treatment were recorded on visual analog scales from 0 to 10 (pain: 0, no pain; 10, maximum pain; satisfaction with treatment: 0, extremely dissatisfied; 10, maximal satisfaction). A follow-up examination was arranged at six weeks and consisted of a standardized history and examination. On a separate sheet patients were asked to give a final assessment of their satisfaction with the treatment (visual analog scale, 0 10) and level of personal activity (0 100 percent). Results are expressed as mean, median, and range. Statistical significance was determined by the Wilcoxon two-sample test for each day. Then the P values were combined by the method of the sum of logs. Table 6. Immediate Postoperative Assessment of Ease of Handling by the Surgeon Operating time was compared by the Welch twosample t-test. Assessments of operative results and ease of handling were compared with Pearson s chisquared test with simulated P value. Statistical analysis was done with the statistical software R1.9.1 (ISBN ). RESULTS Simple 22 (88%) 19 (76%) Slightly awkward 2 (8%) 4 (16%) Complicated 1 (4%) 2 (8%) P value = Table 7. Postoperative Course Immediate complications Urinary Retention 2 (8%) 4 (16%) Bleeding 1 (4%) Total 3 (12%) 4 (16%) First defecation Days: median/mean (range) 2/3 (1 5) 2/2 (1 4) Spontaneous 19 (76%) 17 (68%) Suppository/enema 6 (24%) 8 (42%) Hospital stay Days: median/mean (range) 5/5 (2 10) 4/4 (2 10) Table 8. Analgesic Requirements Analgesia during hospital stay 1. Metamizole drops All All 2. Diclofenac 3 50 mg All All or ibuprofen mg 3. Opiates (on demand) Tramadol 20 drops 6 (24%) 8 (32%) Intramuscular morphine 1 (4%) Analgesia on discharge None 3 (12%) 2 (8%) Metamizole 13 (52%) 17 (68%) Paracetamol 1 (4%) 1 (4%) Diclofenac 6 (24%) 5 (20%) Tramadol 2 (8%) 0 Median duration of analgesic therapy 14 days 16 days No major difference was found in the duration of operation (P = 0.19, Table 4). Not surprisingly, the six cases with combined LigaSure hemorrhoidectomy

4 1520 KRAEMER ET AL Dis Colon Rectum, August 2005 Figure 1. Mean pain score (visual analog score: 0 10) (P value = 0.99). and anodermal flap plasty were slightly more time consuming than the other cases. Immediate postoperative results (Table 5) were judged to be optimal or satisfactory in 96 percent of the cases in the LigaSure group compared with 88 percent of the cases in the stapler group (P = 0.44). Technical handling of the procedure was found to be slightly awkward or complicated in 12 percent and 24 percent, respectively (P = 0.55, Table 6). Both subjective surgical assessments, therefore, showed a favorable trend toward the LigaSure group without reaching the level of significance. Postoperative course is summarized in Table 7. There were no significant differences in terms of immediate complications, time to and mode of first defecation, and hospitalization. Likewise, there were no relevant differences in analgesic requirements (Table 8). Mean and median pain scores (Fig. 1) show a remarkably close correlation between both groups (combined P value for both complete analyses = 0.99). If at all, there was again a trend in favor of the LigaSure group during the first week. Median patient satisfaction (P = 1, Fig. 2) and median selfassessment of level of personal activity (P = 0.99, Fig. 3) were almost identical in both groups and without significant variations. Overall, the level of satisfaction with treatment was high irrespective of the operative method. However, the level of personal activity was clearly restricted during the first two weeks, with median values gradually increasing from around 40 to 60 percent. Stable median activity levels of 80 percent and above were reached by the middle of the third week in both treatment groups. Again, no differences were found at the six-week follow-up (Table 9): In both groups, 84 percent of patients had no residual complaints and local examination was inconspicuous and without relevant findings in 92 percent. Satisfaction with treatment remained high, and level of personal activity was fully restored in the great majority of patients. DISCUSSION It has been shown that for hemorrhoidal surgery both LigaSure and stapler cause less pain than diathermy or scissor dissection. 4 11,13 16 This study attempted to establish which of the less painful alternatives proves best in an unselected series of patients with hemorrhoidal disease. Apart from the all impor-

5 Vol. 48, No. 8 STAPLER VS. LIGASURE FOR HEMORRHOIDS 1521 Figure 2. Median patient satisfaction (visual analog score: 0 10) (P value = 1). Figure 3. Median self-assessment of activity (preoperative state = 100 percent) (P value = 0.99). Table 9. Six Weeks of Follow-Up Complaints None 21 (84%) 21 (84%) Blood 4 (16%) 3 (12%) Irritation, itching, moisture 1 (4%) 2 (8%) Pain on defecation 3 (12%) 1 (4%) Incontinence 0 0 Examination Unremarkable 23 (92%) 23 (92%) Mucosal prolapse 0 2 (8%) Stricture 1 (4%) 0 Fissure 1 (4%) 0 Satisfaction with treatment (VAS) Median/mean (range) 10/10 (7 10) 9/10 (5 10) Self-assessment of personal activity (%) Median/mean (range) 100/95 (70 100) 100/90 (70 100) VAS = visual analog scale. tant pain issue, certain other aspects were also investigated such as operative result, technical handling, and patient satisfaction. Overall, both methods were found to be surprisingly equivalent in all major aspects analyzed. In fact, postoperative pain scores, patient satisfaction, and self-assessment of activity were almost identical in both groups of patients. It is remarkable that in none of the numerous investigated factors were any significant differences found. If at all there was a slightly favorable trend for LigaSure with respect to surgical assessment of imme-

6 1522 KRAEMER ET AL Dis Colon Rectum, August 2005 diate postoperative result and ease of handling. This favorable impression was more marked in cases with advanced hemorrhoidal disease (extensive skin tags, fourth-degree piles). Stapling does improve but not remove these pathologies which, therefore, are either left or dealt with in a conventional manner, usually by excision. It is peculiar how most studies dealing with stapled hemorrhoidopexy somehow manage to elude this issue. One may suspect that in some studies there is an unspecified selection bias toward hemorrhoidal cases suitable for stapling. This selection does not quite reflect the daily realities of specialized coloproctologic service. Even although it remains difficult to grasp how fourth-degree hemorrhoids, which by definition are fixed externally, are treated by stapling alone, the combination of stapling and conventional surgery is useful. Stapling improves the local situation and, thus, the need for conventional resection is less extensive and less painful. In practice, because of the slightly favorable immediate postoperative results and certain technical advantages, LigaSure is now used whenever there is a need for more extensive excision or anodermal reconstruction, such as in fourth-degree piles. The stapling technique is used primarily in patients with third-degree hemorrhoids (prolapsing but reducible) without extensive additional findings. However, according to our data, the potential advantage of a differentiated use of both methods along the lines just mentioned is rather modest. Both methods can therefore be used safely and without major disadvantage for the patient regardless of stage and extent of hemorrhoidal disease. Patient satisfaction was high with both treatment modalities (Fig. 2). Nevertheless, hemorrhoidal surgery does cause pain and temporary restrictions of personal activity in the majority of patients, irrespective of the operative method used. It took our patients three weeks before median levels of pain and personal activity were largely normalized. This is an improvement compared with the four to six weeks convalescence following the Milligan Morgan-type surgery. This improvement, under certain provisions depending on the health care setting, does justify the higher costs. ACKNOWLEDGMENT The authors thank Pablo E. Verde of the Koordinierungszentrum Klinische Studien der Universität Düsseldorf for the statistical analysis. REFERENCES 1. Brisinda G, Civello IM, Maria G. Hemorrhoidectomy: painful choice [letter]. Lancet 2000;355: Engel AF, Eijsbouts QA. Haemorrhoidectomy: painful choice [letter]. Lancet 2000;355: MacRae HM, McLeod RS. Comparison of hemorrhoidal treatment modalities. A meta-analysis. Dis Colon Rectum 1995;38: Ganio E, Altomare D-F, Gabrielli F, Milito G, Canuti S. Prospective randomized multicentre trial comparing stapled with open haemorrhoidectomy. Br J Surg 2001; 88: Hasse C, Sitter H, Brune M, Wollenteit I, Lorenz W, Rothmund M. Haemorrhoidectomy: conventional excision versus resection with the circular stapler. Prospective, randomized study. Dtsch Med Wochenschr 2004; 129: Ho Y-H, Cheong W-K, 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: Khalil K-H, O Bichere A, Sellu D. Randomized clinical trial of sutured versus stapled closed haemorrhoidectomy. Br J Surg 2000;87: Kirsch J-J, Staude G, Herold A. Hämorrhoidektomien nach Longo und Milligan-Morgan. Prospektive Vergleichsstudie mit 300 Patienten. Chirurg 2001;72: Rowsell M, Bello M, Hemingway D-M. Circumferential mucosectomy (stapled haemorrhoidectomy) versus conventional haemorrhoidectomy: randomised controlled trial. Lancet 2000;355: Schmidt MP, Fischbein J, Shatavi H. hemorrhoidectomy versus conventional procedures a clinical study. Zentralbl Chir 2002;127: Shalaby R, Desoky A. Randomized clinical trial of stapled versus Milligan-Morgan haemorrhoidectomy. Br J Surg 2001;88: Seow-Choen F. Stapled haemorrhoidectomy: pain or gain. Br J Surg 2001;88: Chung YC, Wu HJ. Clinical experience of sutureless closed hemorrhoidectomy with LigaSure. Dis Colon Rectum 2003;46: Franklin EJ, Seetharam S, Lowney J, Horgan PG. Randomized, clinical trial of Ligasure vs. conventional diathermy in hemorrhoidectomy. Dis Colon Rectum 2003; 46: Milito G, Gargiani M, Cortese F. Randomised trial comparing LigaSure haemorrhoidectomy with the diathermy dissection operation. Tech Coloproctol 2002;6: Thorbeck CV, Montes MF. Haemorrhoidectomy: randomised controlled clinical trial of Ligasure compared with Milligan-Morgan operation. Eur J Surg 2002;168: