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

Completed

• Conditions: Complicated diverticular disease; infection of diverticula; 10013535

• Registration Number: NL-OMON32858
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 533

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is time-to-recovery with a 6-month follow-up period.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are time to discharge from hospital, occurrence of<br /><br>complicated diverticulitis requiring surgery or percutaneous treatment,<br /><br>morbidity, health related quality of life, readmission rate, recurrence rate,<br /><br>medical and non-medical costs, and antibiotic resistance/sensitivity.</p><br>