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

Not Applicable

Recruiting

• Conditions: Rectal Prolapse; Obstructive Defecation Syndrome; Chronic Constipation
• Interventions: Procedure: Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection; Procedure: Modified Laparoscopic Ventral Mesh Rectopexy

• Registration Number: NCT03060330
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-18
• Study First Posted: 2017-02-23
• Study Start: 2017-04-26
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-12
• Last Update Posted: 2022-03-15
• Primary Completion: 2025-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LVMR with STARR	Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection	Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
LVMR	Modified Laparoscopic Ventral Mesh Rectopexy	Modified Laparoscopic Ventral Mesh Rectopexy

Primary Outcome Measures

Name	Time	Method
Changes in the ODS score (ODS-S)	Baseline and 12 months after surgery	The primary outcome measure will be the change in total ODS score (ODS-S) measured at 12 months after surgery.

Secondary Outcome Measures

Name	Time	Method
Changes in the Patient Assessment of Constipation- Quality of Life score (PAC-QoL)	Baseline, 1, 3, 6, and 12 months after surgery	This is a measure of efficacy.
Changes in Cleveland Clinic Fecal Incontinence Score (CCFI)	Baseline, 1, 3, 6, and 12 months after surgery	This is a measure of efficacy.
Changes in Fecal Incontinence Quality of Life Scale (FIQoL)	Baseline, 1, 3, 6, and 12 months after surgery	This is a measure of efficacy.
Radiological outcome as assessed by defecography	Baseline and 12 months after surgery	This is a measure of efficacy.
Postoperative complications	0 to 12 months after surgery	Monitoring of complications started in the hospital and is followed up in the outpatient setting until 12 months after surgery.
Changes in Health-Related Quality of Life	Baseline, 1, 3, 6, and 12 months after surgery	SF-36 version 1 will be used to measure changes in the health-related quality of life. This is a measure of efficacy.
Changes in the ODS score (ODS-S)	Baseline, 1, 3, 6, and 12 months after surgery	This is a measure of efficacy.

Trial Locations

Locations (1)

Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China