Surgery options for obstructed defecation syndrome
Obstructed Defecation Caused by Rectal Prolapse and Rectocele: Laparoscopic Ventral Rectopexy Alone Versus Laparoscopic Ventral Rectopexy Combined With Stapled Trans-anal Rectal Resection
This study is testing two different surgical options for women with obstructed defecation syndrome to see which one helps them feel better and improves their bowel function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Renmin Hospital of Wuhan University Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT03060330 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares two surgical approaches for treating obstructed defecation syndrome (ODS) in women: laparoscopic ventral mesh rectopexy (LVMR) alone and LVMR combined with stapled trans-anal rectal resection (STARR). The study aims to evaluate the functional and anatomical outcomes of these procedures in patients suffering from ODS, characterized by symptoms such as excessive straining and incomplete bowel evacuation. By focusing on minimally invasive techniques, the trial seeks to establish a more effective treatment strategy for this common condition. High-level prospective studies on ODS treatments are currently lacking, making this comparison particularly valuable.
Who should consider this trial
Good fit: Ideal candidates are women with obstructed defecation syndrome who have not responded to medical therapy and have specific anatomical issues such as rectal prolapse.
Not a fit: Patients with slow transit constipation, previous rectal or anal surgery, or other significant pelvic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective surgical treatment option for women suffering from obstructed defecation syndrome.
How similar studies have performed: While there is a lack of high-level prospective studies on ODS treatments, the surgical techniques being compared are established methods, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wuhan, Hubei
- Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Tao Fu, MD
- Email: futao1975@tom.com
- Phone: 86-13720120190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.