Diverticulitis: Antibiotics or Close Observation? (DIABOLO)
Diverticulitis
About this trial
This is an interventional treatment trial for Diverticulitis focused on measuring multicenter randomized, open label, clinical trial, acute uncomplicated (mild) diverticulitis, treatment strategies, management of diverticulitis, antibiotics, observation and supportive care, cost analysis, economic evaluation
Eligibility Criteria
Inclusion Criteria:
- Only left-sided uncomplicated (mild) acute diverticulitis;
- 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 diverticulitis is defined according the modified Hinchey/Ambrosetti staging, only stages 1a and 1b and "mild" diverticulitis (1a Confined pericolic inflammation, 1b Confined small (smaller than 5cm) pericolic abscess) are included;
- All patients with informed consent.
Exclusion Criteria:
- Previous radiological (ultrasound and/or CT) proven episode of diverticulitis;
- Colonic cancer;
- Inflammatory bowel disease (ulcerative colitis, Crohn's disease);
- Hinchey stages 2, 3 and 4 or "severe" diverticulitis according to the Ambrosetti criteria, which require surgical or percutaneous treatment;
- Disease with expected survival of less than 6 months;
- Contraindication for the use of the study medication (e.g. patients with advanced renal failure or allergy to antibiotics used in this study);
- Pregnancy, breastfeeding;
- ASA (American Society of Anaesthesiologists) classification > III;
- Immunocompromised patients;
- Clinical suspicion of bacteraemia (i.e. sepsis);
- The inability of reading/understanding and filling in the questionnaires;
- Antibiotic use in the 4 weeks before admittance.
Sites / Locations
- Ziekenhuisgroep Twente
- Flevo Hospital
- Meander Hospital
- Academic Medical Center
- BovenIJ Hospital
- Onze Lieve Vrouwe Gasthuis
- Sint Lucas Andreas Hospital
- Slotervaart Hospital
- VU Medical Center
- Gelre Hospitals
- Rijnstate Hospital
- Rode Kruis Hospital
- Reinier de Graaf Gasthuis
- Albert Schweitzer Hospital
- Kennemer Hospital
- Ziekenhuisgroep Twente
- Tergooi Hospital
- Spaarne Hospitals
- Westfries Gasthuis
- Sint Antonius Hospital
- Erasmus Medical Center
- Ikazia Hospital
- Sint Franciscus Gasthuis
- Máxima Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
Conservative strategy with antibiotics
Liberal strategy without antibiotics
Hospital admission Intravenous fluids and at least 48 hours of intravenous antibiotics and subsequently switch to oral antibiotics if tolerated (otherwise continuation i.v.) to complete a full 10-day treatment duration Adequate pain relief Oral intake as tolerated Daily monitoring
Admission only if discharge criteria are not met No initial antibiotics Intravenous fluids only for those not tolerating oral liquids Adequate pain relief Oral intake as tolerated Daily monitoring when admitted to the hospital Self-monitoring at home (Patient diary with temperature and VAS pain score until full recovery)