A Multicenter Prospective Non-Randomized Study Comparing Ferguson Hemorrhoidectomy and Transanal Hemorrhoidal Dearterialization for Prolapsed, Nonincarcerated, Reducible Hemorrhoids: A Study Protocol.

INTRODUCTION

Current evidence suggests that transanal hemorrhoidal dearterialization (THD) is associated with less postoperative pain and faster recovery than Ferguson hemorrhoidectomy. However, there is some uncertainty regarding the durability of the therapeutic effect in terms of recurrent disease. Objective and significance: The aim of this study will be to evaluate the outcome of THD compared to Ferguson hemorrhoidectomy in terms of recurrence rate at 1-year follow-up.

METHODS

This is a multicenter, parallel-arm, non-randomized prospective study comparing Ferguson hemorrhoidectomy and THD in terms of recurrence rate at one year. The primary endpoint is recurrence rate at one year defined as prolapsing internal hemorrhoids at physical examination. Secondary endpoints include the following postoperative complications: urinary retention, constipation (requiring laxative or emergency room visit), dysuria, pruritis ani, anal pain, anal stenosis, unhealed wound, fissure, fecal urgency, and flatus or stool incontinence. Adults older than 18 years with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns at physical examination will be included in one of the study arms: Ferguson hemorrhoidectomy and THD. Surgeons with proven expertise in hemorrhoids surgery will enroll patients undergoing Ferguson hemorrhoidectomy and THD (not both). Each participating surgeon will enroll a maximum of 10 patients. Ethics and Dissemination: This study was approved by the Institutional Review Boards of Stony Brook University (previously) and New York Medical College (currently), and registered in ClinicalTrials.gov (NCT03245086). The findings of the study will be published in a peer-reviewed journal.