A multicenter randomized clinical trial investigating the cost-effectiveness of treatment strategies with or without antibiotics for uncomplicated acute diverticulitis - DIABOLO trial

Academisch Medisch Centrum0 个研究点目标入组 533 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•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.

•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);
•11. The inability of reading/understanding and filling in the questionnaires;
•12. Antibiotic use in the 4 weeks before admittance.

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