Improving the Treatment of Acute Uncomplicated Diverticulitis in Routine Care

NCT07824180 | Not Yet Recruiting

• 1 other identifier: ORL-CHIR-040_aud
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diverticulitis

Outcome Measures

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.

  Within 90 days after diagnosis

Secondary Outcomes (5)

• Antibiotic use

  Within 90 days after diagnosis

• Adherence to the standardized treatment approach

  At the initial treatment decision

• Outpatient versus inpatient management

  At the initial treatment decision

• Hospital admission

  Within 30 days after diagnosis

• Recurrence of diverticulitis

  Within 24 months after diagnosis

Study Arms (2)

Antibiotic Treatment

OTHER

Participants with acute uncomplicated diverticulitis who receive antibiotic treatment according to the standardized treatment approach.

Other: standardized treatment algorithm

No Antibiotic Treatment Arm Description:

OTHER

Participants with acute uncomplicated diverticulitis who are managed without antibiotics according to the standardized treatment approach.

Other: standardized treatment algorithm

Interventions

standardized treatment algorithm OTHER

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.

Antibiotic Treatment; No Antibiotic Treatment Arm Description:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

MeSH Terms

Conditions

Diverticulitis

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Dimitri Christoforidis, MD

  EOC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitri Christoforidis, MD

CONTACT

Dimitrios.Christoforidis@eoc.ch

Elena Porro, Msc

CONTACT

0041918117038; ricerca.chirurgiaorl@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Before-and-after study comparing a retrospective control cohort treated according to usual care with a prospective cohort treated after introduction of a standardized treatment approach. The two cohorts are enrolled in different time periods and participants are not randomized. In the prospective phase, participants are managed with or without antibiotics based on clinical, laboratory, and CT findings.

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09