Clinical trial NCT03060330: Laparoscopic Ventral Mesh Rectopexy Combined With or Without Stapled Trans-anal Rectal Resection for Obstructed Defecation Syndrome
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Defecation Syndrome
Chronic Constipation
Rectal Prolapse
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in the ODS score (ODS-S)
timeFrame: Baseline and 12 months after surgery
Secondary outcomes:
measure: Postoperative complications
timeFrame: 0 to 12 months after surgery
measure: Changes in the Patient Assessment of Constipation- Quality of Life score (PAC-QoL)
timeFrame: Baseline, 1, 3, 6, and 12 months after surgery
measure: Changes in Health-Related Quality of Life
timeFrame: Baseline, 1, 3, 6, and 12 months after surgery
measure: Changes in Cleveland Clinic Fecal Incontinence Score (CCFI)
timeFrame: Baseline, 1, 3, 6, and 12 months after surgery
measure: Changes in Fecal Incontinence Quality of Life Scale (FIQoL)
timeFrame: Baseline, 1, 3, 6, and 12 months after surgery
measure: Radiological outcome as assessed by defecography
timeFrame: Baseline and 12 months after surgery
measure: Changes in the ODS score (ODS-S)
timeFrame: Baseline, 1, 3, 6, and 12 months after surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University
state: Hubei
Study officials:
References: