Bowel Function/QoL After Elective Sigmoidectomy vs. Conservative Management for Recurrent Uncompl… (NCT03994978) | Clinical Trial Compass
RecruitingNot Applicable
Bowel Function/QoL After Elective Sigmoidectomy vs. Conservative Management for Recurrent Uncomplicated Diverticulitis
Switzerland252 participantsStarted 2019-07-08
Plain-language summary
The decision to perform a surgical intervention or not after recovery from repeated uncomplicated episodes of acute diverticulitis remains controversial and the literature shows different conflicting approaches based on low-quality evidence.The goal of this trial is to achieve a better understanding of the impact of surgery on bowel function and QoL in patients with recurrent uncomplicated sigmoid diverticulitis in order to develop treatment guidelines.
Who can participate
Age range
18 Years
Sex
ALL
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 with recurrent uncomplicated diverticulitis and surgical indication for sigmoid resection
* Patients with recurrent uncomplicated diverticulitis and non-surgical indication for conservative management
* Confirmation of at least one episode of acute uncomplicated diverticulitis in computed tomography
Exclusion Criteria:
* Patients aged under 18.
* Patients unable to understand an informed consent.
* Patients with chronic pain disorder.
* Patients with sigmoid fistulas
* Emergency operations.
* Pregnant women or lactation.
* Patients with other severe gastrointestinal diseases, such as inflammatory bowel diseases (IBD), carcinoma or immunologic disorders.
* Patients unable to perform surgery or high-risk patients according to the American Society of Anesthesiology (ASA 4 grade or higher)
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
Change in grade of fecal incontinence incontinence score
Timeframe: change from baseline to 12 months after intervention
2
Change in grade of constipation
Timeframe: change from baseline to 12 months after intervention