Complicated diverticular disease infection of diverticula
Conditions
Interventions
Intervention: Conservative strategy with antibiotics: supportive measures and
at least 48 hours of intravenous antibiotics (and therefore admittance to the
hospital) and subsequently switch to oral
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is time-to-recovery with a 6-month follow-up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are time to discharge from hospital, occurrence of complicated diverticulitis requiring surgery or percutaneous treatment, morbidity, health related quality of life, readmission rate, recurrence rate, medical and non-medical costs, and antibiotic resistance/sensitivity. | — |
Countries
Netherlands
Outcome results
None listed