A multicenter randomized clinical trial investigating the cost-effectiveness of treatment strategies with or without antibiotics for uncomplicated acute diverticulitis.
- Conditions
- Diverticulitis, antibiotics, observation
- Registration Number
- NL-OMON27328
- Lead Sponsor
- Academic Medical Center, department of Surgery
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 534
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 (1a Confined pericoloc inflammation, 1b Confined small (smaller than 5cm) pericolic abscess) are included. In the attachments we have added a flow chart, showing systematically the inclusion criteria and the following steps after inclusion;
1. Previous radiological (ultrasound and/or CT) proven episode of diverticulitis;
2. Colonic cancer;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is time-to-full-recovery with a follow-up period of 6 months. Recovery is defined by all of the following criteria: discharged from the hospital (out-patient), normal diet (defined by tolerating vast food and more than 1L of fluid orally), temperature < 38.0 °C, and VAS pain score < 4, with no use of daily pain medication and resuming to pre-illness working activities; as assessed by questionnaires and an out-patient clinic visit.
- Secondary Outcome Measures
Name Time Method 1. Direct and indirect medical costs at 6 months follow-up;<br /><br>2. Occurrence of complicated diverticulitis defined as abscess, perforation, stricture and/or fistula and need for percuteaneas drainage and\or operation;<br /><br>3. Antibiotic resistance/sensitivity;<br /><br>4. Morbidity, like urinary tract infection, pneumonia, etc;<br /><br>5. Mortality;<br /><br>6. Readmission rate and recurrence rate at 12 and 24 months follow-up;<br /><br>7. Changes in health status and valuation over time will be measured using generic and disease specific quality of life questionnaires (Euro-Qol 5D, Short Form 36 (SF-36) and the Gastro-intestinal Quality of Life Index (Giqli)) on admission and after 3, 6, 12 and 24 months.<br>