Surgery for Lower Rectum Deep Endometriosis (Segmental/Disc) - Prospective Comparison of Digestiv… (NCT04398641) | Clinical Trial Compass
UnknownNot Applicable
Surgery for Lower Rectum Deep Endometriosis (Segmental/Disc) - Prospective Comparison of Digestive Symptoms and Pain
Austria300 participantsStarted 2020-07-01
Plain-language summary
Several studies show a significant drop in pain scores, improved fertility outcomes and amelioration of impaired sexual functioning in women following surgical resection of colorectal endometriosis. However, intermediate and long-term bowel dysfunction may occur as a consequence of radical surgery with typical symptoms such as constipation, feeling of incomplete evacuation, clustering of stools and urgency. This is described as low anterior resection syndrome (LARS).
The primary aim of this study is the prospective comparison of two surgical approaches for full thickness excision, i.e. transanal disc excision (TADE) and nerve-vessel sparing limited segmental resection (NVSSR), regarding gastrointestinal functional outcomes using the LARS / Gastrointestinal Quality of Life Index (GIQLI) by Eypasch questionnaires.
Who can participate
Age range
18 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:
* Premenopausal women undergoing full thickness excision of rectal deep endometriosis (DE) resulting in an anastomotic height ≤7 cm distance from the anal verge
Exclusion Criteria:
* Diagnosed or suspected malignancy
* Previous colorectal surgery
* Previous history of chronic inflammatory diseases of the gastrointestinal tract and/or chronic defecation dysfunction related to other factors such as birth trauma etc.
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.
What they're measuring
1
Comparison of gastrointestinal functional outcomes between groups using the LARS questionnaire
Timeframe: 4 to 24 months
2
Comparison of gastrointestinal functional outcomes between groups using the GIQLI by Eypasch questionnaire