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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


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.

Clinical Details

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

Secondary outcome:

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


Readmission rate

Indirect medical costs

Acute diverticulitis recurrence rate

Acute diverticulitis recurrence rate

Health status

Health status

Health status

Health status


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

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

Additional Information

DIABOLO trial website

Related publications:

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

Page last updated: August 20, 2015

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