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DIABOLO Trial: A Multicenter Randomized Clinical Trial Investigating the Cost-effectiveness of Treatment Strategies With or Without Antibiotics for Uncomplicated Acute Diverticulitis.

This study is currently Recruiting

April 2010 By Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

First Recieved on April 22, 2010

Last Updated on July 5, 2011

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Identifier: NCT01111253

Purpose

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

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Accepts Healthy Volunteers
Criteria

Inclusion Criteria: - Only left-sided uncomplicated (mild) acute diverticulitis; - 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 diverticulitis is defined according the modified Hinchey/Ambrosetti staging, only stages 1a and 1b and "mild" diverticulitis (1a Confined pericolic inflammation, 1b Confined small (smaller than 5cm) pericolic abscess) are included; - All patients with informed consent. Exclusion Criteria: - Previous radiological (ultrasound and/or CT) proven episode of diverticulitis; - Colonic cancer; - Inflammatory bowel disease (ulcerative colitis, Crohn's disease); - Hinchey stages 2, 3 and 4 or "severe" diverticulitis according to the Ambrosetti criteria, which require surgical or percutaneous treatment; - Disease with expected survival of less than 6 months; - Contraindication for the use of the study medication (e.g. patients with advanced renal failure or allergy to antibiotics used in this study); - Pregnancy, breastfeeding; - ASA (American Society of Anaesthesiologists) classification > III; - Immunocompromised patients; - Clinical suspicion of bacteraemia (i.e. sepsis); - The inability of reading/understanding and filling in the questionnaires; - Antibiotic use in the 4 weeks before admittance.

Investigators

  • Investigator: Marie A Boermeester, MD, PhD, MSc - Principal Investigator - Academic Medical Center - University of Amsterdam

Locations

  • Ziekenhuisgroep Twente

    Almelo, Netherlands

  • Flevo Hospital

    Almere, Netherlands

  • Meander Hospital

    Amersfoort, Netherlands

  • BovenIJ Hospital

    Amsterdam, Netherlands

  • Academic Medical Center

    Amsterdam, Netherlands

  • VU Medical Center

    Amsterdam, Netherlands

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, Netherlands

  • Sint Lucas Andreas Hospital

    Amsterdam, Netherlands

  • Slotervaart Hospital

    Amsterdam, Netherlands

  • Gelre Hospitals

    Apeldoorn, Netherlands

  • Rode Kruis Hospital

    Beverwijk, Netherlands

  • Reinier de Graaf Gasthuis

    Delft, Netherlands

  • Albert Schweitzer Hospital

    Dordrecht, Netherlands

  • Kennemer Hospital

    Haarlem, Netherlands

  • Ziekenhuisgroep Twente

    Hengelo, Netherlands

  • Tergooi Hospital

    Hilversum, Netherlands

  • Spaarne Hospitals

    Hoofddorp, Netherlands

  • Westfries Gasthuis

    Hoorn, Netherlands

  • Sint Antonius Hospital

    Nieuwegein, Netherlands

  • Ikazia Hospital

    Rotterdam, Netherlands

  • Sint Franciscus Gasthuis

    Rotterdam, Netherlands

  • Erasmus Medical Center

    Rotterdam, Netherlands

  • M?xima Hospital

    Veldhoven, Netherlands

Conditions related to this trial:

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