Improving the Treatment of Acute Uncomplicated Diverticulitis in Routine Care (AUD)

September 11, 2026 updated by: Ente Ospedaliero Cantonale, Bellinzona

From Guidelines to Real-world Practice: a Pragmatic Before and After Study on the Treatment of Acute Uncomplicated Diverticulitis (AUD) Based on a Risk Factor Driven Treatment Algorithm (AUD Management Algorithm Protocol)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

  • Diverticulitis of the right or transverse colon

    -.Alternative diagnosis explaining the participant's symptoms

  • No possibility of completing the 90-day follow-up
  • Inability to provide informed consent for the prospective phase

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Antibiotic Treatment
Participants with acute uncomplicated diverticulitis who receive antibiotic treatment according to the standardized treatment approach.
Other: standardized treatment algorithm
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.
Other: No Antibiotic Treatment Arm Description:
Participants with acute uncomplicated diverticulitis who are managed without antibiotics according to the standardized treatment approach.
Other: standardized treatment algorithm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment failure
Time Frame: Within 90 days after diagnosis
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.
Within 90 days after diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic use
Time Frame: Within 90 days after diagnosis
Proportion of participants receiving antibiotics
Within 90 days after diagnosis
Adherence to the standardized treatment approach
Time Frame: At the initial treatment decision
Proportion of participants whose management is consistent with the standardized treatment approach.
At the initial treatment decision
Outpatient versus inpatient management
Time Frame: At the initial treatment decision
roportion of participants initially managed as outpatients versus inpatients.
At the initial treatment decision
Hospital admission
Time Frame: Within 30 days after diagnosis
Proportion of participants readmitted to hospital.
Within 30 days after diagnosis
Recurrence of diverticulitis
Time Frame: Within 24 months after diagnosis
Proportion of participants experiencing recurrence of diverticulitis.
Within 24 months after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Investigators

  • Principal Investigator: Dimitri Christoforidis, MD, EOC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

September 11, 2026

First Submitted That Met QC Criteria

September 11, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORL-CHIR-040_aud

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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