RANDOMIZED CONTROLLED TRIAL
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A prospective, randomized trial comparing the short- and long-term results of doppler-guided transanal hemorrhoid dearterialization with mucopexy versus excision hemorrhoidectomy for grade III hemorrhoids.

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.

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