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…
ID
Source
Brief title
Condition
- Diverticular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is time-to-recovery with a 6-month follow-up period.
Secondary outcome
Secondary endpoints are time to discharge from hospital, 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.
Background summary
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. With conservative
treatment many patients receive 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.
Study 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.
Study design
A randomized, open label, multicenter clinical trial comparing treatment of
acute uncomplicated diverticulitis with antibiotics to observation and
supportive care alone.
Intervention
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). Discharge when the discharge criteria are met.
Control:Liberal strategy without antibiotics: supportive measures only.
Observation and oral intake as tolerated. Admittance only if discharge criteria
are not met on presentation at the Emergency Department.
Study burden and risks
Both treatment regimens in this study are commonly used in the Netherlands and
are considered standard of care. The investigational products used in the study
have been widely used for a long time already and toxicity and possible side
effects are well documented. Treatment of uncomplicated diverticulitis with
these antibiotics is common practise in most countries. The risk of omitting
antibiotics is probably very low but an independent safety commission closely
monitors the adverse effects after every 25 patients. The only difference
compared to standard treatment is patients have to fill out three quality of
life questionnaires on admission and after 3, 6, 12 and 24 months and feces for
culture, so the additional burden for participants is considered minimal.
Postbus 22660
1100 DD Amsterdam
NL
Postbus 22660
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1. Only left-sided uncomplicated (mild) acute diverticulitis;
2. 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 diverticultis is defined according the modified Hinchey/Ambrosetti staging, only stages 1a and 1b and "mild" diverticulitis are included;
3. All patients with informed consent.
Exclusion criteria
1. Previous radiological (ultrasound and/or CT) proven episode of diverticulitis;
2. Colonic cancer;
3. Inflammatory bowel disease (ulcerative colitis, Crohn's disease);
4. Hinchey stages 2, 3 and 4 or "severe" diverticulitis according to the Ambrosetti criteria, which require surgical or percutaneous treatment;
5. Disease with expected survival of less than 6 months;
6. Contraindication for the use of the study medication (e.g. patients with advanced renal failure or allergy to antibiotics used in this study);
7. Pregnancy, breastfeeding;
8. ASA (American Society of Anaesthesiologists) classification > III;
9. Immunocompromised patients;
10. Clinical suspicion of bacteraemia (i.e. sepsis);
11. The inability of reading/understanding and filling in the questionnaires;
12. Antibiotic use in the 4 weeks before admittance.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-015004-26-NL |
| CCMO | NL29615.018.09 |
| OMON | NL-OMON27328 |