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Diverticulitis: Antibiotics or Close Observation?

2014-07-23 21:09:25 | BioPortfolio

Summary

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diverticulitis

Intervention

Amoxicillin-clavulanate

Location

Ziekenhuisgroep Twente
Almelo
Netherlands

Status

Recruiting

Source

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:25-0400

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Medical and Biotech [MESH] Definitions

A fixed-ratio combination of amoxicillin trihydrate (see AMOXICILLIN), an aminopenicillin, and potassium clavulanate (see CLAVULANIC ACID), a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.

Inflammation of a DIVERTICULUM or diverticula.

A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.

Diseases of the DIVERTICULUM often due to infection and/or inflammation (DIVERTICULITIS).

Inflammation of the COLONIC DIVERTICULA, generally with abscess formation and subsequent perforation.

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