Actively Recruiting
Preoperative vs Postoperative Bowel Function and Quality of Life in Patients Undergoing Elective Sigmoidectomy vs Conservative Management for Recurrent Uncomplicated Diverticulitis (FRESCO-Trial)
Led by University Hospital, Basel, Switzerland · Updated on 2026-05-22
252
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of surgery compared to conservative treatment on bowel function and quality of life in patients with recurrent uncomplicated sigmoid diverticulitis. This study aims to improve understanding of how elective sigmoidectomy impacts these outcomes to help develop clearer treatment guidelines, given the current conflicting recommendations and low-quality evidence on this topic. The study compares two groups: patients undergoing elective sigmoidectomy and those receiving conservative management for recurrent uncomplicated diverticulitis. The surgical group undergoes sigmoid resection, while the conservative group receives non-surgical care. Both groups are observed to assess changes in bowel function and quality of life over time. Participants will be monitored for changes in fecal incontinence and constipation scores from baseline to 12 months after intervention. Researchers will also evaluate gastrointestinal quality of life and erectile function over the same period. The study includes assessments before and after treatment to understand long-term impacts on patient well-being.
CONDITIONS
Brief Title
Bowel Function/QoL After Elective Sigmoidectomy vs. Conservative Management for Recurrent Uncomplicated Diverticulitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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, 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to hospital discharge
Participants in the surgical group undergo elective sigmoid resection followed by immediate recovery and care.
1 surgical visit and hospital stay
Duration - 12 months after surgery
Participants in the surgical group are monitored to assess bowel function, quality of life, and recovery after surgery.
Regular follow-up visits over 12 months
Duration - 12 months
Participants in the conservative group with recurrent uncomplicated diverticulitis are observed over time to assess bowel function and quality of life without surgery.
Regular assessments during 12 months
Trial Site Locations
Total: 1 location
1
St. Claraspital Basel
Basel, Switzerland
Actively Recruiting
Research Team
B
Bettina Wölnerhanssen, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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