Laparoscopic Ventral Mesh Rectopexy Combined With or Without Stapled Trans-anal Rectal Resection for Obstructed Defecation Syndrome

Renmin Hospital of Wuhan University126 enrolled

Overview

Obstructed defecation syndrome (ODS) is a common problem in women. Rectal prolapse and rectocoele are frequently identified in patients with ODS. Surgery is the only definite treatment for those patients and is preferably performed minimally invasive. The most used procedures are laparoscopic ventral mesh rectopexy (LVMR) and stapled trans-anal rectal resection (STARR). However, high-level prospective studies on treatment strategies for ODS currently are lacking and, thus, no consensus exist regarding the optimal treatment for patients with ODS. This study aimed to compare LVMR alone and LVMR combined with STARR evaluating functional and anatomical results.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

126

Conditions

Obstructive Defecation Syndrome Chronic Constipation Rectal Prolapse

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients affected by obstructed defecation with a minimum ODS score of 10 * External rectal prolapse or high-grade internal rectal prolapse * Often experience excessive straining, sense of incomplete evacuation, and/or prolonged time for complete evacuation when attempting a bowel movement * Have experienced ODS symptoms for at least 12 months prior to enrollment * Failure of at least 6 months of medical therapy * American Society of Anesthesiologists (ASA) score of no more than 3 Exclusion Criteria: * Slow transit constipation * Anismus resistant to conventional treatment * No demonstrable pelvic anatomical problem * Previous rectal or anal surgery * Recto-vaginal fistula * Pregnancy * Previous pelvic radiotherapy * Severe proctitis or significant rectal fibrosis * Evidence of colorectal neoplasia, carcinoma, or inflammatory bowel disease * Perineal infection * High-grade endometriosis * Morbid obesity * A hostile abdomen * Psychological instability

Outcomes

Primary Outcomes

Changes in the ODS score (ODS-S)

The primary outcome measure will be the change in total ODS score (ODS-S) measured at 12 months after surgery.

Time frame: Baseline and 12 months after surgery

Secondary Outcomes

Postoperative complications

Monitoring of complications started in the hospital and is followed up in the outpatient setting until 12 months after surgery.

Time frame: 0 to 12 months after surgery

Changes in the Patient Assessment of Constipation- Quality of Life score (PAC-QoL)