Diverticulitis: Antibiotics or Close Observation?
Information source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diverticulitis
Intervention: Amoxicillin-clavulanate (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official(s) and/or principal investigator(s):
Marie A Boermeester, MD, PhD, MSc, Principal Investigator, Affiliation: Academic Medical Center - University of Amsterdam
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.
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.
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
A randomized, open label, multicenter clinical trial comparing treatment of acute
uncomplicated diverticulitis with antibiotics to observation and supportive care alone.
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.
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).
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.
Official title: DIABOLO Trial: A Multicenter Randomized Clinical Trial Investigating the Cost-effectiveness of Treatment Strategies With or Without Antibiotics for Uncomplicated Acute Diverticulitis.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time-to-full-recovery
Direct medical costs
Occurrence of complicated diverticulitis defined as abscess, perforation, stricture and/or fistula and need for percutaneous drainage and/or operation
Predefined side-effects of initial antibiotic treatment
Morbidity, like urinary tract infection, pneumonia, etc
Indirect medical costs
Acute diverticulitis recurrence rate
Acute diverticulitis recurrence rate
Minimum age: 18 Years.
Maximum age: N/A.
- 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.
- 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.
Locations and Contacts
Ziekenhuisgroep Twente, Almelo, Netherlands
Flevo Hospital, Almere, Netherlands
Meander Hospital, Amersfoort, Netherlands
Academic Medical Center, Amsterdam, Netherlands
BovenIJ Hospital, Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands
Sint Lucas Andreas Hospital, Amsterdam, Netherlands
Slotervaart Hospital, Amsterdam, Netherlands
VU Medical Center, Amsterdam, Netherlands
Gelre Hospitals, Apeldoorn, Netherlands
Rijnstate Hospital, Arnhem, 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
Erasmus Medical Center, Rotterdam, Netherlands
Ikazia Hospital, Rotterdam, Netherlands
Sint Franciscus Gasthuis, Rotterdam, Netherlands
Máxima Hospital, Veldhoven, Netherlands
DIABOLO trial website
de Korte N, Unlü C, Boermeester MA, Cuesta MA, Vrouenreats BC, Stockmann HB. Use of antibiotics in uncomplicated diverticulitis. Br J Surg. 2011 Jun;98(6):761-7. doi: 10.1002/bjs.7376. Epub 2011 Jan 6. Review.
de Korte N, Kuyvenhoven JP, van der Peet DL, Felt-Bersma RJ, Cuesta MA, Stockmann HB. Mild colonic diverticulitis can be treated without antibiotics. A case-control study. Colorectal Dis. 2012 Mar;14(3):325-30. doi: 10.1111/j.1463-1318.2011.02609.x.
de Korte N, Klarenbeek BR, Kuyvenhoven JP, Roumen RM, Cuesta MA, Stockmann HB. Management of diverticulitis: results of a survey among gastroenterologists and surgeons. Colorectal Dis. 2011 Dec;13(12):e411-7. doi: 10.1111/j.1463-1318.2011.02744.x.
Unlü C, de Korte N, Daniels L, Consten EC, Cuesta MA, Gerhards MF, van Geloven AA, van der Zaag ES, van der Hoeven JA, Klicks R, Cense HA, Roumen RM, Eijsbouts QA, Lange JF, Fockens P, de Borgie CA, Bemelman WA, Reitsma JB, Stockmann HB, Vrouenraets BC, Boermeester MA; Dutch Diverticular Disease 3D Collaborative Study Group. A multicenter randomized clinical trial investigating the cost-effectiveness of treatment strategies with or without antibiotics for uncomplicated acute diverticulitis (DIABOLO trial). BMC Surg. 2010 Jul 20;10:23. doi: 10.1186/1471-2482-10-23.
Draaisma WA, van de Wall BJ, Vermeulen J, Unlu C, de Korte N, Swank HA. [Treatment for diverticulitis not thoroughly researched]. Ned Tijdschr Geneeskd. 2009;153:A648. Review. Dutch.
Ünlü C, Daniels L, Vrouenraets BC, Boermeester MA. A systematic review of high-fibre dietary therapy in diverticular disease. Int J Colorectal Dis. 2012 Apr;27(4):419-27. doi: 10.1007/s00384-011-1308-3. Epub 2011 Sep 16. Review.
Starting date: May 2010
Last updated: October 26, 2012