Abstract
Background: Laparoscopic ventral mesh rectopexy (LVMR) and stapled trans-anal rectal resection (STARR) are effective and well-recognized treatments for symptoms of obstructed defecation syndrome (ODS) in the context of rectal prolapse and rectocele. However, recurrence and postoperative complications including symptomatic grade III/IV hemorrhoids develop in patients undergo LVMR. It was hypothesized that adding STARR to LVMR is effective in improving the clinical symptoms and functional outcomes and reducing the postoperative complications after repair of ODS.
Methods/Design: In this prospective, single-blind, randomised trial, consecutive patients aged 18 years or older at a single center in China with ODS are randomly assigned (1:1) to either LVMR or LVMR plus STARR. Functional assessment is done preoperatively and 12 months postoperatively. The primary outcome is the rate of complications started in the hospital and is followed up in the outpatient setting until 12 months after surgery. Patients and those assessing the outcomes were masked to the procedure. The primary analysis is done in the per-protocol population. Outcomes are assessed in the entire cohort.
Discussion: This study will add to the scant literature regarding surgical management of ODS.
Laparoscopic ventral mesh rectopexy versus laparoscopic ventral mesh rectopexy combined with trans-anal rectal resection in the treatment of obstructed defecation syndrome: study protocol for a randomized controlled trial