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

NCT03060330 | Recruiting

• 1 other identifier: LVMRSTARRODS2017
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Defecation Syndrome; Chronic Constipation; Rectal Prolapse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Postoperative complications

  0 to 12 months after surgery

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

  Baseline, 1, 3, 6, and 12 months after surgery

• Changes in Health-Related Quality of Life

  Baseline, 1, 3, 6, and 12 months after surgery

• Changes in Cleveland Clinic Fecal Incontinence Score (CCFI)

  Baseline, 1, 3, 6, and 12 months after surgery

• Changes in Fecal Incontinence Quality of Life Scale (FIQoL)

  Baseline, 1, 3, 6, and 12 months after surgery

Study Arms (2)

LVMR

EXPERIMENTAL

Modified Laparoscopic Ventral Mesh Rectopexy

Procedure: Modified Laparoscopic Ventral Mesh Rectopexy

LVMR with STARR

EXPERIMENTAL

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

Interventions

Modified Laparoscopic Ventral Mesh Rectopexy PROCEDURE

This group will undergo modified laparoscopic ventral mesh rectopexy alone

LVMR

Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection PROCEDURE

This group will undergo modified laparoscopic ventral mesh rectopexy combined with modified stapled trans-anal rectal resection

LVMR with STARR

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

MeSH Terms

Conditions

Rectal Prolapse

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tao Fu, MD

CONTACT

86-13720120190; futao1975@tom.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Gastrointestinal Surgery II

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 23, 2017
• Study Start: April 26, 2017
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)