NCT03994978 Bowel Function/QoL After Elective Sigmoidectomy vs. Conservative Management for Recurrent Uncomplicated Diverticulitis
| NCT ID | NCT03994978 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Diverticulitis of Sigmoid |
| Study Type | OBSERVATIONAL |
| Enrollment | 252 participants |
| Start Date | 2019-07-08 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 252 participants in total. It began in 2019-07-08 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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)
Contact & Investigator
Bettina Wölnerhanssen, MD
STUDY CHAIR
St. Clara Research Ltd.
Frequently Asked Questions
Who can join the NCT03994978 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diverticulitis of Sigmoid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03994978 currently recruiting?
Yes, NCT03994978 is actively recruiting participants. Contact the research team at bettina.woelnerhanssen@claraspital.ch for enrollment information.
Where is the NCT03994978 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT03994978 clinical trial?
NCT03994978 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Bettina Wölnerhanssen, MD at St. Clara Research Ltd.. The trial plans to enroll 252 participants.