Improving the Treatment of Acute Uncomplicated Diverticulitis in Routine Care

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEnte Ospedaliero Cantonale, Bellinzona

About this trial

Acute uncomplicated diverticulitis is often treated with antibiotics, although current evidence shows that antibiotics are not always necessary. This study will evaluate whether a more standardized approach to treatment can reduce unnecessary antibiotic use without increasing the risk of treatment failure.

The study will compare patients treated before and after the new treatment approach is introduced in participating Swiss hospitals. Information on treatment, hospital admissions, complications and recurrence of diverticulitis will be collected. Patients will be followed for up to 24 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

CT-confirmirmed acute uncomplicated diverticulitis of the left colon

Ability to provide informed consent for participants in the prospective phase

Disqualifiers

Complicated acute diverticulitis, defined as diverticulitis with abscess, perforation (free air), fistula, or distant free fluid

Diverticulitis of the right or transverse colon

No possibility of completing the 90-day follow-up

Inability to provide informed consent for the prospective phase

Trial design

Design model

Parallel

Treatments tested in this trial

  • standardized treatment algorithm

    Other intervention

    A standardized treatment approach based on clinical findings, laboratory results, comorbidities, immunosuppression status, and CT findings is introduced to support treatment decisions in patients with acute uncomplicated diverticulitis. Depending on these factors, patients may be managed with or without antibiotics.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Antibiotic TreatmentOther 1 intervention
Group B: No Antibiotic Treatment Arm Description:Other 1 intervention

Trial outcomes

Primary outcomes

1

Treatment failure

Treatment failure is defined as a composite outcome including progression to complicated diverticulitis requiring percutaneous abscess drainage or surgery, delayed initiation of antibiotics after initial management without antibiotics, or unplanned hospital admission following initial outpatient treatment.

Time frame
Within 90 days after diagnosis

Secondary outcomes

1

Antibiotic use

Proportion of participants receiving antibiotics

Time frame
Within 90 days after diagnosis
2

Adherence to the standardized treatment approach

Proportion of participants whose management is consistent with the standardized treatment approach.

Time frame
At the initial treatment decision
3

Outpatient versus inpatient management

Proportion of participants initially managed as outpatients versus inpatients.

Time frame
At the initial treatment decision
4

Hospital admission

Proportion of participants readmitted to hospital.

Time frame
Within 30 days after diagnosis

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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