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

Chronic Constipation Clinical Trial

Official title:

Obstructed Defecation Caused by Rectal Prolapse and Rectocele: Laparoscopic Ventral Rectopexy Alone Versus Laparoscopic Ventral Rectopexy Combined With Stapled Trans-anal Rectal Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03060330
• Other study ID #: LVMRSTARRODS2017
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2017
• Est. completion date: April 2026

Study information

• Verified date: March 2022
• Source: Renmin Hospital of Wuhan University
• Contact: Tao Fu, MD
• Phone: 86-13720120190
• Email: futao1975[@]tom.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: April 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation
• Obstructive Defecation Syndrome
• Prolapse
• Rectal Prolapse
• Syndrome

Intervention

Procedure:
• Modified Laparoscopic Ventral Mesh Rectopexy
This group will undergo modified laparoscopic ventral mesh rectopexy alone
• Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
This group will undergo modified laparoscopic ventral mesh rectopexy combined with modified stapled trans-anal rectal resection

Locations

Country	Name	City	State
China	Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

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