Clinical Trial: Diverticulitis: Antibiotics or Close Observation?

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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" dive

Detailed Summary:
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Current Primary Outcome: Time-to-full-recovery [ Time Frame: 6 months follow-up ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Dates:
Date Received: April 22, 2010
Date Started: May 2010
Date Completion: October 2014
Last Updated: October 26, 2012
Last Verified: October 2012