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

Wuhan University

Status: Enrolling

Conditions: Rectal Prolapse; Chronic Constipation; Obstructive Defecation Syndrome

Treatments: Procedure: Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection; Procedure: Modified Laparoscopic Ventral Mesh Rectopexy

Study type: Interventional

Funder types: Other

Identifiers

NCT03060330

LVMRSTARRODS2017

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 2 patient groups

LVMR

Experimental group

Description:

Modified Laparoscopic Ventral Mesh Rectopexy

Treatment:

Procedure: Modified Laparoscopic Ventral Mesh Rectopexy

LVMR with STARR

Experimental group

Description:

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

Treatment:

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