Diverticulitis
Conditions
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.
Interventions
OTHERstandardized 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.
Sponsors
Ente Ospedaliero Cantonale, Bellinzona
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibiotic use | Within 90 days after diagnosis | Proportion of participants receiving antibiotics |
| Adherence to the standardized treatment approach | At the initial treatment decision | Proportion of participants whose management is consistent with the standardized treatment approach. |
| Outpatient versus inpatient management | At the initial treatment decision | roportion of participants initially managed as outpatients versus inpatients. |
| Hospital admission | Within 30 days after diagnosis | Proportion of participants readmitted to hospital. |
| Recurrence of diverticulitis | Within 24 months after diagnosis | Proportion of participants experiencing recurrence of diverticulitis. |
Contacts
CONTACTDimitri Christoforidis, MD
CONTACTElena Porro, Msc
PRINCIPAL_INVESTIGATORDimitri Christoforidis, MD
EOC
Outcome results
None listed