NL-OMON32858
Completed
Not Applicable
A multicenter randomized clinical trial investigating the cost-effectiveness of treatment strategies with or without antibiotics for uncomplicated acute diverticulitis - DIABOLO trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Complicated diverticular disease
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 533
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Only left\-sided uncomplicated (mild) acute diverticulitis;
- •2\. Clinical suspicion of acute diverticulitis. For acute diagnostic work\-up: ultrasound or CT proven diverticulitis. In the case of diverticulitis\-negative ultrasound in clinically suspected patients an intravenous contrast\-enhanced CT scan is mandatory for confirmation of diverticulitis or exclusion of other pathology. CT for Hinchey/Ambrosetti classification (which is a CT\-based classification system) is needed for all patients, but can be delayed 1 day in those with ultrasound diagnosis. Staging diverticultis is defined according the modified Hinchey/Ambrosetti staging, only stages 1a and 1b and mild diverticulitis are included;
- •3\. All patients with informed consent.
Exclusion Criteria
- •1\. Previous radiological (ultrasound and/or CT) proven episode of diverticulitis;
- •2\. Colonic cancer;
- •3\. Inflammatory bowel disease (ulcerative colitis, Crohn's disease);
- •4\. Hinchey stages 2, 3 and 4 or severe diverticulitis according to the Ambrosetti criteria, which require surgical or percutaneous treatment;
- •5\. Disease with expected survival of less than 6 months;
- •6\. Contraindication for the use of the study medication (e.g. patients with advanced renal failure or allergy to antibiotics used in this study);
- •7\. Pregnancy, breastfeeding;
- •8\. ASA (American Society of Anaesthesiologists) classification \> III;
- •9\. Immunocompromised patients;
- •10\. Clinical suspicion of bacteraemia (i.e. sepsis);
Outcomes
Primary Outcomes
Not specified
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