Obstructed Defecation Caused by Rectal Prolapse and Rectocele: Laparoscopic Ventral Rectopexy Alone Versus Laparoscopic Ventral Rectopexy Combined With Stapled Trans-anal Rectal Resection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Changes in the ODS score (ODS-S)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
LVMR
Modified Laparoscopic Ventral Mesh Rectopexy
Intervention: Modified Laparoscopic Ventral Mesh Rectopexy (Procedure)
LVMR with STARR
Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
Intervention: Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection (Procedure)
Outcomes
Primary Outcomes
Changes in the ODS score (ODS-S)
Time Frame: 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 Outcomes
- Radiological outcome as assessed by defecography(Baseline and 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 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)
- Postoperative complications(0 to 12 months after surgery)
- Changes in Health-Related Quality of Life(Baseline, 1, 3, 6, and 12 months after surgery)
- Changes in the ODS score (ODS-S)(Baseline, 1, 3, 6, and 12 months after surgery)
Investigators
Tao Fu
Chief of Department of Gastrointestinal Surgery II
Renmin Hospital of Wuhan University