Diverticulitis: Antibiotics or Close Observation?
DIABOLO
DIABOLO Trial: A Multicenter Randomized Clinical Trial Investigating the Cost-effectiveness of Treatment Strategies With or Without Antibiotics for Uncomplicated Acute Diverticulitis.
6 other identifiers
interventional
533
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2010
Longer than P75 for phase_4
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2010
CompletedFirst Posted
Study publicly available on registry
April 27, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 29, 2012
October 1, 2012
2.9 years
April 22, 2010
October 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time-to-full-recovery
6 months follow-up
Secondary Outcomes (13)
Direct medical costs
6 months follow-up
Occurrence of complicated diverticulitis defined as abscess, perforation, stricture and/or fistula and need for percutaneous drainage and/or operation
24 months follow-up
Predefined side-effects of initial antibiotic treatment
24 months follow-up
Morbidity, like urinary tract infection, pneumonia, etc
24 months follow-up
Mortality
24 months follow-up
- +8 more secondary outcomes
Study Arms (2)
Conservative strategy with antibiotics
ACTIVE COMPARATOR* 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
Liberal strategy without antibiotics
NO INTERVENTION* 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)
Interventions
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.
Eligibility Criteria
You may qualify if:
- Only left-sided uncomplicated (mild) acute diverticulitis;
- All patients with informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Ziekenhuisgroep Twente
Almelo, Netherlands
Flevo Hospital
Almere Stad, 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
Related Publications (7)
de Korte N, Unlu 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.
PMID: 21523694BACKGROUNDde 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.
PMID: 21689302BACKGROUNDde 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.
PMID: 21819518BACKGROUNDUnlu 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.
PMID: 20646266BACKGROUNDDraaisma 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. Dutch.
PMID: 19857313BACKGROUNDUnlu 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.
PMID: 21922199BACKGROUNDDaniels L, Unlu C, de Korte N, van Dieren S, Stockmann HB, Vrouenraets BC, Consten EC, van der Hoeven JA, Eijsbouts QA, Faneyte IF, Bemelman WA, Dijkgraaf MG, Boermeester MA; Dutch Diverticular Disease (3D) Collaborative Study Group. Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT-proven uncomplicated acute diverticulitis. Br J Surg. 2017 Jan;104(1):52-61. doi: 10.1002/bjs.10309. Epub 2016 Sep 30.
PMID: 27686365DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie A Boermeester, MD, PhD, MSc
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 22, 2010
First Posted
April 27, 2010
Study Start
May 1, 2010
Primary Completion
April 1, 2013
Study Completion
October 1, 2014
Last Updated
October 29, 2012
Record last verified: 2012-10