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Diverticulitis: Antibiotics or Close Observation? (DIABOLO)

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ClinicalTrials.gov Identifier: NCT01111253
Recruitment Status : Unknown
Verified October 2012 by M.A. Boermeester, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Active, not recruiting
First Posted : April 27, 2010
Last Update Posted : October 29, 2012
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Dutch Digestive Diseases Foundation
Information provided by (Responsible Party):
M.A. Boermeester, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Tracking Information
First Submitted Date  ICMJE April 22, 2010
First Posted Date  ICMJE April 27, 2010
Last Update Posted Date October 29, 2012
Study Start Date  ICMJE May 2010
Estimated Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2010)
Time-to-full-recovery [ Time Frame: 6 months follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01111253 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2010)
  • Direct medical costs [ Time Frame: 6 months follow-up ]
  • Occurrence of complicated diverticulitis defined as abscess, perforation, stricture and/or fistula and need for percutaneous drainage and/or operation [ Time Frame: 24 months follow-up ]
  • Predefined side-effects of initial antibiotic treatment [ Time Frame: 24 months follow-up ]
    e.g. antibiotic resistance/sensitivity pattern, allergy
  • Morbidity, like urinary tract infection, pneumonia, etc [ Time Frame: 24 months follow-up ]
  • Mortality [ Time Frame: 24 months follow-up ]
  • Readmission rate [ Time Frame: 6 months follow-up ]
  • Indirect medical costs [ Time Frame: 6 months follow-up ]
  • Acute diverticulitis recurrence rate [ Time Frame: 12 months follow-up ]
  • Acute diverticulitis recurrence rate [ Time Frame: 24 months follow-up ]
  • Health status [ Time Frame: 3 months follow-up ]
    Changes and valuation over time (compared to t=0) will be measured using generic and disease specific quality of life questionnaires (Euro-Qol 5D, Short Form 36 (SF-36) and the Gastro-intestinal Quality of Life Index (Giqli))
  • Health status [ Time Frame: 6 months follow-up ]
    Changes and valuation over time (compared to t=0 and 3 months) will be measured using generic and disease specific quality of life questionnaires (Euro-Qol 5D, Short Form 36 (SF-36) and the Gastro-intestinal Quality of Life Index (Giqli))
  • Health status [ Time Frame: 12 months follow-up ]
    Changes and valuation over time (compared to t=0, 3 and 6 months) will be measured using generic and disease specific quality of life questionnaires (Euro-Qol 5D, Short Form 36 (SF-36) and the Gastro-intestinal Quality of Life Index (Giqli))
  • Health status [ Time Frame: 24 months follow-up ]
    Changes and valuation over time (compared to t=0, 3, 6 and 12 months) will be measured using generic and disease specific quality of life questionnaires (Euro-Qol 5D, Short Form 36 (SF-36) and the Gastro-intestinal Quality of Life Index (Giqli))
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diverticulitis: Antibiotics or Close Observation?
Official Title  ICMJE DIABOLO Trial: A Multicenter Randomized Clinical Trial Investigating the Cost-effectiveness of Treatment Strategies With or Without Antibiotics for Uncomplicated Acute Diverticulitis.
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diverticulitis
Intervention  ICMJE Drug: Amoxicillin-clavulanate

Amoxicillin-clavulanate: 4 times a day 1200 mg and switch to oral administration 3 times a day 625 mg after two days, for a total duration of 10 days.

In case of allergy to Amoxicillin-clavulanate: intravenous administration ciprofloxacin 2 times a day 400 mg and metronidazole 3 times a day 500 mg. In case of oral administration ciprofloxacin 2 times a day 500 mg and metronidazole 3 times a day 500 mg. For a total duration of 10 days.

Other Name: Augmentin.
Study Arms  ICMJE
  • Active Comparator: Conservative strategy with antibiotics
    • Hospital admission
    • Intravenous fluids and at least 48 hours of intravenous antibiotics and subsequently switch to oral antibiotics if tolerated (otherwise continuation i.v.) to complete a full 10-day treatment duration
    • Adequate pain relief
    • Oral intake as tolerated
    • Daily monitoring
    Intervention: Drug: Amoxicillin-clavulanate
  • No Intervention: Liberal strategy without antibiotics
    • Admission only if discharge criteria are not met
    • No initial antibiotics
    • Intravenous fluids only for those not tolerating oral liquids
    • Adequate pain relief
    • Oral intake as tolerated
    • Daily monitoring when admitted to the hospital
    • Self-monitoring at home (Patient diary with temperature and VAS pain score until full recovery)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 26, 2010)
533
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2014
Estimated Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01111253
Other Study ID Numbers  ICMJE 09/233
2009-015004-26 ( EudraCT Number )
NL29615.018.09 ( Registry Identifier: Nederlands Trial Register (=Dutch Trial Registry) )
ABR 29615 ( Other Identifier: CCMO Registry )
80-82310-97-10039 ( Other Grant/Funding Number: ZonMW (Organisation for Health Research and Development) )
WO 08-54 ( Other Grant/Funding Number: MLDS )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.A. Boermeester, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Sponsor  ICMJE Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators  ICMJE
  • ZonMw: The Netherlands Organisation for Health Research and Development
  • Dutch Digestive Diseases Foundation
Investigators  ICMJE
Principal Investigator: Marie A Boermeester, MD, PhD, MSc Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PRS Account Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP