Evaluating quality of life after surgery for diverticulitis
DATE Trial: Outcomes and Quality of Life in Patients With Early Versus Elective Resection in Acute Complicated and Chronic Recurrent Left-sided Diverticulitis
This study tests whether having surgery sooner or later for diverticulitis affects how well patients feel and recover afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kepler University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Linz, Austria and 3 other locations) |
| Trial ID | NCT05942833 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the quality of life outcomes in patients with acute complicated and chronic recurrent left-sided diverticulitis. Patients will be randomized into two groups: one receiving early left hemicolectomy within 7 to 10 days of admission, and the other undergoing elective resection 6 to 8 weeks after initial treatment. Quality of life will be assessed using standardized scoring systems, including the Gastrointestinal Quality of Life Index and the Short-form 36 Score, at various points post-surgery. The study aims to determine the impact of timing of surgery on patient recovery and overall well-being.
Who should consider this trial
Good fit: Ideal candidates include adults with acute complicated left-sided diverticulitis or recurrent diverticulitis without complications.
Not a fit: Patients who are under 18, pregnant, or have significant comorbidities that prevent them from undergoing surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved quality of life for patients undergoing surgery for diverticulitis.
How similar studies have performed: Other studies have shown promising results with early surgical intervention in diverticulitis, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent to participate in the study * CDD Type 2a, 2b: acute complicated left-sided diverticulitis * CDD Type 3b: relapsing diverticulitis without complications (\>2 episodes within 2 years) * Acute presentation * Inflammation located in the left-sided colon * Inflammation is CT proven or ultrasound confirmed from experienced radiologists Exclusion Criteria: * \< 18 years * Pregnancy * BMI \> 55kg/m2 * Current colorectal carcinoma in the left-sided colon * Oral and/or intravenous corticosteroid * Ongoing chemotherapy * Status post left hemicolectomy * Patients who cannot take care of themselves at home or are unable to follow instructions * Patients who are not fit for surgery (anesthesia, expert knowledge from specialists) and will not benefit from surgery
Where this trial is running
Linz, Austria and 3 other locations
- Ordensklinikum Elisabethinen Linz — Linz, Austria, Austria (Recruiting)
- Krankenhaus Barmherzige Schwestern Linz — Linz, Upper Austria, Austria (Recruiting)
- Kepler University Hospital — Linz, Upper Austria, Austria (Recruiting)
- Universitätsklinikum Mannheim — Mannheim, Mannheim, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Andreas Shamiyeh, Dr. — Kepler University Hospital Linz
- Study coordinator: Sandra Raab, Dr.
- Email: sandra.raab@kepleruniklinikum.at
- Phone: +43 (0)5 7680 83 - 78470
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.