Rationale
The prevalence of colonic diverticular disease is increasing in Western countries.
Approximately 10 to 25% of patients with diverticular disease will eventually develop an
episode of acute diverticulitis. Currently conservative treatment often includes antibiotic
therapy. This advice lacks sound evidence and is merely based on experts' opinion. An old
clinical dogma is being clarified with this randomized trial.
Objective
Primary objective is to evaluate whether or not using antibiotics reduces to time to full
recovery of an attack of uncomplicated (mild) diverticulitis. Secondary objectives are to
evaluate complications, quality of life, readmission rate, recurrence rate, medical and
non-medical costs, and antibiotic resistance/sensitivity in both groups.
Hypothesis
The investigators hypothesis is that in the treatment of uncomplicated (mild) acute
diverticulitis, supportive treatment without antibiotics is a more cost-effective approach
than conservative treatment with antibiotics with respect to time-to-recovery as primary
outcome.
Study design
A randomized, open label, multicenter clinical trial comparing treatment of acute
uncomplicated diverticulitis with antibiotics to observation and supportive care alone.
Study population
Patients 18 years or older are eligible for inclusion if they have a diagnosis of acute
uncomplicated diverticulitis as demonstrated by imaging. Only patients with stages 1a and 1b
according to Hinchey's classification or "mild" diverticulitis according to the Ambrosetti
criteria are included.
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 antibiotics if tolerated (total duration of 10 days).
Control
Liberal strategy without antibiotics: supportive measures only. Observation and oral intake
as tolerated. Admittance only if discharge criteria are not met on presentation.
Main study parameters/endpoints
The primary endpoint is time-to-recovery with a 6-month follow-up period. Secondary endpoints
are 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.
Phase:
Phase 4
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators:
Dutch Digestive Diseases Foundation ZonMw: The Netherlands Organisation for Health Research and Development