Tissue selecting technique mega-window stapler combined with anal canal epithelial preservation operation for the treatment of severe prolapsed hemorrhoids: A study protocol for a randomized controlled trial

INTRODUCTION: Hemorrhoidal disease is one of the most common and frequently occurring benign anorectal disorders, presented with bleeding and prolapsed, and surgery is the main and effective method for severe prolapsed hemorrhoids. Yet, the recurrence rate after procedure for prolapse and hemorrhoids (PPH) is significantly higher. To reduce the recurrence rate and protect the anus function, we try to carry out a randomized, controlled, prospective study to compare the efficacy and recurrence rate of tissue selecting technique (TST) with mega-window stapler (TST-MS) combined with anal canal epithelial preservation operation and PPH combined with external hemorrhoidectomy and inferior internal hemorrhoid ligation operation for the treatment of severe prolapsed hemorrhoids. METHODS: This study is a single-center, evaluator-blinded, randomized, controlled clinical trial. Participants meet the inclusion and exclusion criteria in this RCT will be randomly divided into treatment group (TST-MS combined with anal canal epithelial preservation operation group) and control group (PPH combined with external hemorrhoidectomy and inferior internal hemorrhoid ligation operation) in a 1:1 ratio according to a computer-generated randomization list. The outcomes of recurrence, anal function, intraoperative variables, and postoperative complications will be recorded at different follow-ups. CONCLUSION: The findings of the study will help to explore the efficacy and recurrence rate of TST-MS combined with anal canal epithelial preservation operation on the treatment of severe prolapsed hemorrhoids. TRIAL REGISTRATION: This study protocol was registered in open science framework (OSF). (Registration number: DOI 10.17605 / OSF.IO / 4JYNF).