Laparoscopic Ventral Mesh Rectopexy Combined With or Without Stapled Trans-anal Rectal Resection … (NCT03060330) | Clinical Trial Compass
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Laparoscopic Ventral Mesh Rectopexy Combined With or Without Stapled Trans-anal Rectal Resection for Obstructed Defecation Syndrome
China126 participantsStarted 2017-04-26
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.