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

• Sponsor: Renmin Hospital of Wuhan University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03060330
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 107.2
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Defecation Syndrome; Chronic Constipation; Rectal Prolapse	Procedure: Modified Laparoscopic Ventral Mesh Rectopexy; Procedure: Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 26, 2017
• Anticipated Primary Completion Date: Apr 1, 2025
• Anticipated Study Completion Date: Apr 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LVMR Modified Laparoscopic Ventral Mesh Rectopexy	Procedure: Modified Laparoscopic Ventral Mesh Rectopexy; This group will undergo modified laparoscopic ventral mesh rectopexy alone
Experimental: LVMR with STARR Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection	Procedure: 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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. Changes in Cleveland Clinic Fecal Incontinence Score (CCFI) [Baseline, 1, 3, 6, and 12 months after surgery]

   This is a measure of efficacy.

5. Changes in Fecal Incontinence Quality of Life Scale (FIQoL) [Baseline, 1, 3, 6, and 12 months after surgery]

   This is a measure of efficacy.

6. Radiological outcome as assessed by defecography [Baseline and 12 months after surgery]

   This is a measure of efficacy.

7. Changes in the ODS score (ODS-S) [Baseline, 1, 3, 6, and 12 months after surgery]

   This is a measure of efficacy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University	Wuhan	Hubei	China	430060

Sponsors and Collaborators

• Renmin Hospital of Wuhan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tao Fu, Chief of Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University
• ClinicalTrials.gov Identifier: NCT03060330
• Other Study ID Numbers: LVMRSTARRODS2017
• First Posted: Feb 23, 2017
• Last Update Posted: Mar 15, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rectal Prolapse; Syndrome; Constipation; Prolapse

Study Results

No Results Posted as of Mar 15, 2022