BACKGROUND: Few randomized trials have compared the results of Doppler-guided transanal hemorrhoid dearterialization with mucopexy and excisional open hemorrhoidectomy. Few studies have reported long-term results. OBJECTIVE: The aim of this study is to evaluate the results of Doppler-guided transanal hemorrhoid dearterialization with mucopexy compared with excisional open hemorrhoidectomy in patients with grade III hemorrhoids. DESIGN: This is a prospective randomized study registered at clinicaltrials.gov (NCT01263431). A power analysis assessed the study's sample size. Patients were randomly assigned to undergo either hemorrhoidectomy or Doppler-guided hemorrhoid dearterialization plus mucopexy. The χ test, Mann-Whitney U test, Student t test, and a regression model were used, as appropriate. SETTINGS: This study was conducted at the Department of Surgery, San Raffaele Scientific Institute, Milan, Italy. PATIENTS: Fifty consecutive patients were treated for grade III hemorrhoids from July to November 2010. MAIN OUTCOME MEASURES: The primary outcome was postoperative pain. The secondary outcomes included postoperative morbidity, the resumption of social and/or working activity, patient satisfaction, and the relapse of symptoms at 1 and 24 months. RESULTS: No major complications occurred in either group. The median visual analog scale scores for pain in the hemorrhoidectomy and Doppler-guided dearterialization plus mucopexy groups on days 1, 7, 14, and 30 were 7 vs 5.5, 3 vs 2.5, 1 vs 0, and 0 vs 0 (p> 0.05). The median work resumption day was the 22nd in the hemorrhoidectomy group and the 10th in the Doppler-guided dearterialization plus mucopexy group (p = 0.09). Patient satisfaction at 1 and 24 postoperative months, with the use of a 4-point scale, was 3 vs 4 and 4 vs 4 (p > 0.05). During the follow-up, 2 patients in the dearterialization group required ambulatory treatment, and 1 patient in each group required further surgery for symptom relapse. LIMITATIONS: Nonvalidated questionnaires were used in the follow-up. Cost analysis was not performed. CONCLUSION: Compared with hemorrhoidectomy, dearterialization with mucopexy resulted in similar postoperative pain and morbidity, and a similar long-term cure rate.
RCT Entities:
BACKGROUND: Few randomized trials have compared the results of Doppler-guided transanal hemorrhoid dearterialization with mucopexy and excisional open hemorrhoidectomy. Few studies have reported long-term results. OBJECTIVE: The aim of this study is to evaluate the results of Doppler-guided transanal hemorrhoid dearterialization with mucopexy compared with excisional open hemorrhoidectomy in patients with grade III hemorrhoids. DESIGN: This is a prospective randomized study registered at clinicaltrials.gov (NCT01263431). A power analysis assessed the study's sample size. Patients were randomly assigned to undergo either hemorrhoidectomy or Doppler-guided hemorrhoid dearterialization plus mucopexy. The χ test, Mann-Whitney U test, Student t test, and a regression model were used, as appropriate. SETTINGS: This study was conducted at the Department of Surgery, San Raffaele Scientific Institute, Milan, Italy. PATIENTS: Fifty consecutive patients were treated for grade III hemorrhoids from July to November 2010. MAIN OUTCOME MEASURES: The primary outcome was postoperative pain. The secondary outcomes included postoperative morbidity, the resumption of social and/or working activity, patient satisfaction, and the relapse of symptoms at 1 and 24 months. RESULTS: No major complications occurred in either group. The median visual analog scale scores for pain in the hemorrhoidectomy and Doppler-guided dearterialization plus mucopexy groups on days 1, 7, 14, and 30 were 7 vs 5.5, 3 vs 2.5, 1 vs 0, and 0 vs 0 (p> 0.05). The median work resumption day was the 22nd in the hemorrhoidectomy group and the 10th in the Doppler-guided dearterialization plus mucopexy group (p = 0.09). Patient satisfaction at 1 and 24 postoperative months, with the use of a 4-point scale, was 3 vs 4 and 4 vs 4 (p > 0.05). During the follow-up, 2 patients in the dearterialization group required ambulatory treatment, and 1 patient in each group required further surgery for symptom relapse. LIMITATIONS: Nonvalidated questionnaires were used in the follow-up. Cost analysis was not performed. CONCLUSION: Compared with hemorrhoidectomy, dearterialization with mucopexy resulted in similar postoperative pain and morbidity, and a similar long-term cure rate.
Authors: P Giamundo; A Braini; G Calabro'; N Crea; P De Nardi; F Fabiano; M Lippa; A Mastromarino; A M Tamburini Journal: Tech Coloproctol Date: 2018-08-29 Impact factor: 3.781
Authors: M Trompetto; G Clerico; G F Cocorullo; P Giordano; F Marino; J Martellucci; G Milito; M Mistrangelo; C Ratto Journal: Tech Coloproctol Date: 2015-09-24 Impact factor: 3.781