Chronic Constipation, Obstructive Defecation Syndrome, Rectal Prolapse
Conditions
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.
Interventions
PROCEDUREModified Laparoscopic Ventral Mesh Rectopexy
This group will undergo modified laparoscopic ventral mesh rectopexy alone
PROCEDUREModified 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
Sponsors
Renmin Hospital of Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Changes in Cleveland Clinic Fecal Incontinence Score (CCFI) | Baseline, 1, 3, 6, and 12 months after surgery | This is a measure of efficacy. |
| 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. |
| Radiological outcome as assessed by defecography | Baseline and 12 months after surgery | This is a measure of efficacy. |
| Changes in the ODS score (ODS-S) | Baseline, 1, 3, 6, and 12 months after surgery | This is a measure of efficacy. |
| Changes in Fecal Incontinence Quality of Life Scale (FIQoL) | Baseline, 1, 3, 6, and 12 months after surgery | This is a measure of efficacy. |
Countries
China
Contacts
Primary ContactTao Fu, MD
Outcome results
None listed