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Ligasure™ Precise Vs. Conventional Diathermy for Milligan-Morgan Hemorrhoidectomy: a Prospective, Randomized, Multicenter Tria

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Ligasure™ Precise Vs. Conventional Diathermy for Milligan-Morgan Hemorrhoidectomy: a Prospective, Randomized, Multicenter Tria Ligasure™ Precise vs. Conventional Diathermy for Milligan-Morgan Hemorrhoidectomy: A Prospective, ORIGINAL Randomized, Multicenter Trial CONTRIBUTION D. F. Altomare, M.D.1 G. Milito, M.D.2 R. Andreoli, M.D.3 F. Arcanà, M.D.4 N. Tricomi, M.D.5 C. Salafia, M.D.6 D. Segre, M.D.7 G. Pecorella, M.D.8 A. Pulvirenti d’Urso, M.D.9 N. Cracco, M.D.3 G. Giovanardi, M.D.6 G. Romano, M.D.10 on behalf of the Ligasure™ for Hemorrhoids Study Group 1 Department of Emergency and Organ Transplantation, University of Bari, Italy 2 Department of General Surgery, Tor Vergata University of Rome, Rome, Italy 3 Coloproctological Unit, San Francesco Hospital, Negrar (Verona), Italy 4 Coloproctological Unit, Carmona Hospital, Messina, Italy 5 Coloproctological Unit, Candela Hospital, Palermo, Italy 6 Coloproctological Unit, Ramazzini Hospital, Carpi (Modena), Italy 7 Surgical Unit, Santa Croce Hospital, Cuneo, Italy 8 Vittorio Emanuele Hospital, University of Catania, Catania, Italy 9 Colorectal Unit, Garibaldi Hospital, Catania, Italy 10 Surgical Unit, Moscati General Hospital, Avellino, Italy PURPOSE: Milligan-Morgan hemorrhoidectomy using RESULTS: A total of 273 patients, well matched for age, radiofrequency dissection (Ligasure™) has been proposed gender, working activity and grade of hemorrhoids, were instead of conventional diathermy in view of its potential randomized to two groups: Ligasure™ 146, and diathermy benefits in terms of postoperative anal pain and better 127. The severity of postoperative anal pain was hemostatic control, but the medical literature is still significantly less in the Ligasure group when measured at controversial. This multicenter, randomized, controlled least 12 hours after defecation (P<0.01), whereas it was trial was designed to compare the outcomes between similar at the time of defecation. The Ligasure™ group Ligasure™ and conventional diathermy had significantly lower requirements for painkiller pills. hemorrhoidectomy in the Milligan-Morgan There were no significant differences in early and late procedures in a sufficient number of patients. complications. Return to work and normal activities was significantly faster in the Ligasure™ group. METHODS: Patients with Grades III and IV hemorrhoids were randomized to two groups: Ligasure™ hemorrhoid- CONCLUSION: Ligasure™ hemorrhoidectomy is an ectomy and conventional diathermy. Postoperative anal effective procedure for Grades III and IV hemorrhoids pain was measured by the Visual Analog Scale (VAS) and and facilitates a faster return to work and normal the analgesia required. Postoperative complications, activities by reducing postoperative pain. wound healing, and return to working activities also were evaluated as secondary outcomes. KEY WORDS: Ligasure™; Radiofrequency; Diathermy; Hemorrhoids; Prospective randomized trial; Milligan- Morgan. (Infantino A and Tonizzo CA,(Surgical Unit, Santa Maria dei Battuti Hospital, S Vito al Tagliamento, Italy), Picardo G, Buonanno M (Surgical Unit, Moscati General Hospital, Avellino, Italy), Binda GA he optimal treatment of hemorrhoids is still a hot (colorectal Unit Galliera Hospital Genova, Italy), Di Pascale A and topic in the medical literature, with more than 400 Logrieco G (Surgical Unit Miulli General Hospital, Acquaviva delle T Fonti, Italy), Gilbertoni F (Coloproctological Unit, Ramazzini Hospital, articles listed in PubMed during the last five years. The Carpi (Modena), Italy), Muzi PD (Dept of General Surgery, Tor availability of new techniques and devices has stimulated Vergata University of Rome, Italy), Pezzolla F (IRCCS Castellana researchers to look for the best treatment for curing hem- Grotte, Italy), Tegon G (Proctological Unit Rizzola Hospital, San Donà di Piave, Italy), Herbert Dal Corso (Surgical Unit, Santa Croce Hospital, orrhoids. The ideal technique should combine high safety Cuneo, Italy) and efficacy of the treatment with low postoperative pain Reprints are not available. and discomfort for the patient and with a low-cost treat- Address of correspondence: Donato F. Altomare, M.D., Department of ment. Such considerations must be related to the severity Emergency and Organ Transplantation, General Surgery and Liver of the disease and can be answered only by evidence-based Transplantation Units, University of Bari, Policlinico, piazza G. Cesare, 11, 70124 Bari, Italy. E-mail: [email protected] medicine from randomized, controlled trials. According to 514 DOI: 10.1007/s10350-007-9171-6 VOLUME 51: 514–519 (2008) ©THE ASCRS 2007 PUBLISHED ONLINE:30JANUARY 2008 ALTOMARE ET AL.: RADIOFREQUENCY/DIATHERMY MILLIGAN-MORGAN 515 a recent review of the Cochrane library,1 conventional hem- or IV hemorrhoids limited to one quadrant only, were orrhoidectomy as first described by Milligan and Morgan2 excluded from the study. Preoperative assessment included is still the most widely used and effective treatment for proctologic history and proctologic examination, including patients with symptomatic Grades III and IV hemorrhoids. anoscopy. Full colonoscopy also was performed in patients However, it is associated with significant postoperative older than aged 50 years to rule out colorectal cancer. pain. In every patient, preoperative and postoperative The Ligasure™ Vessel Sealing System (Tyco Healthcare, continence was evaluated by means of the Cleveland Clinic Boulder, CO) is a recently introduced device that uses a scoring system.10 Postoperative pain was monitored daily combination of pressure and electrical energy, which ensures and immediately after any defecation for the first 14 complete coagulation of vessels with minimal surrounding postoperative days and at postoperative Days 21 and 28 by thermal spread and limited tissue charring. For that reason, using a self-administered uninterrupted 0 to 10 cm VAS. it could be an ideal tool for hemorrhoidectomy, because it The operating time, postoperative complications, healing enables effective, bloodless excision of hemorrhoids with time of the anal wounds, and time to return to working minimal tissue trauma, and hence possibly a reduction in activities also were recorded on postoperative Days 7, 14, postoperative pain and wound healing time.3 21, and 28. The requirements of oral analgesics during the Several randomized trials have been performed to postoperative period also were recorded in the two groups. compare postoperative pain after Ligasure™ hemorrhoid- ectomy vs. conventional diathermy hemorrhoidectomy, but Operative Procedure – the results were not univocal.4 8 Although a trend toward All patients were treated preoperatively with a cleansing ene- or a clear reduction of postoperative pain with Ligasure™ ma, a single dose of intravenous 500 mg of metronidazole, hemorrhoidectomy has been suggested in some of the trials and the procedure were performed in lithotomic position. published so far, this finding has not been confirmed by In the LH group the anus was dilated by using an others, although the possibility of a Type II error because of Eisenhammer retractor and the Milligan-Morgan opera- the limited number of patients enrolled in all these studies tion was performed by using Ligasure Precise™ forceps for makes the results unconvincing. On the other hand, a clear all the quadrants. The procedure did not include pedicle demonstration of the advantages of using Ligasure™ instead ligature, use of diathermy, or anal tampon at the end of the of traditional diathermy is essential to justify the increased procedure. cost of the operation using the disposable devices. The CD group received diathermy hemorrhoidectomy The main goal of this study was to compare post- according to the standard technique described by Loder operative pain after Ligasure™ vs. conventional diathermy and Phillips.11 As in the LH group, the procedure did not hemorrhoidectomy in the Milligan-Morgan procedures in include pedicles ligature or anal tampon. a randomized, controlled trial in a sufficient number of The choice of type of anesthesia (local sedation, epi- patients. Secondary outcomes were operating time, postop- dural, or general) was left free. Normal diet was allowed and erative complication rate, healing time of the anal wounds, bulking laxatives were prescribed immediately after surgery. and time to return to working activities. The patients were instructed to irrigate the anal wound at least twice per day. PATIENTS AND METHODS Statistical Analysis Patients with symptomatic Grades III and IV hemorrhoids Data are expressed as median values, and P <0.05 was con- recruited from January to June 2005 in 15 colorectal units sidered statistically significant. The Mann-Whitney U test affiliated to the Italian Society of Colorectal Surgery entered was used to evaluate the differences between Diathermy and the study after written, informed consent had been obtained. Ligasure™ hemorrhoidectomy for postoperative pain, pain They were randomized into two groups—Ligasure™ hem- at defecation, and analgesic requirement. Fisher’s exact test orrhoidectomy (LH) and conventional diathermy (CD)— was used to compare the incidence of postoperative com- by using a centralized, randomization system with permuted plications. The study power was calculated considering as blocks. All surgeons received telephone information about clinically relevant a reduction in postoperative anal pain by the randomized treatment just before the operation from at least 20 percent with an alpha error of 5 percent and beta one of the authors who designed the trial (DFA). error of 10 percent. According
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