DIRECT trial: Diverticulitis Recurrences or Continuing Symptoms Treatment, Operative versus Conservative. A MULTICENTER RANDOMISED CLINICAL TRIAL.
- Conditions
- EN: Diverticulitis, recurrence, recurrences. NL: Diverticulitis, recidief, recidieven.
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 214
Inclusion Criteria
1. Age 18-75 years;
2. Patients presenting with either persisting abdominal complaints and/or frequently recurring diverticulitis after a well documented (CT-scan or sonography) episode of diverticulitis.
Exclusion Criteria
1. Patients with elective or emergency surgery for acute diverticulitis in the past;
2. Patients with an absolute operation indication (perforation with purulent/fecal peritonitis, symptomatic bowel stenosis or fistula);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life (QoL) objectified primarily by the Gastro-intestinal Quality of life Index (GIQLI) and secondarily by EuroQol-5D (EQ-5D), Short-form 36 (SF-36) and Visual Analogue Score (VAS) for pain. Patients are also asked to point out on a 7 point scale whether their health/complaints have improved or deteriorated.
- Secondary Outcome Measures
Name Time Method 1. Mortality;<br /><br>2. Morbidity;<br /><br>3. (In)Direct (non-)health care costs.