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Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without Antibiotics

NCT06517264 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2025-02-25

No results posted yet for this study

Summary

The objective of this clinical trial to evaluate the effectiveness and safety of outpatient treatment without antibiotics compared to outpatient treatment with antibiotics in patients with acute uncomplicated diverticulitis.

The hypotheses are:

* Null Hypothesis (H0): Outpatient treatment without antibiotics in patients with acute uncomplicated diverticulitis is neither safe nor effective and is inferior to outpatient management with antibiotics.
* Alternative Hypothesis (H1): Outpatient treatment without antibiotics in patients with acute uncomplicated diverticulitis is safe, effective, and not inferior to outpatient management with antibiotics.

We compare the rate of complications, therapeutic failure (clinical worsening and readmission) and recurrence between patients who, on an outpatient basis, are administered antibiotics and those who are not.

The patient diagnosed with acute uncomplicated diverticulitis who meets the inclusion criteria is evaluated and examined by a general surgeon. After informing him/her about the pathology, the study will be explained and he/she will be invited to freely participate in it. After accepting and signing the informed consent form, the patient will be included in the study and will be randomly assigned to one of the two treatment arms (outpatient treatment with antibiotics (group A) or without antibiotics (group B).

Conditions

  • Diverticulitis, Colonic

Interventions

DRUG

Antibiotic

antibiotic treatment, analgesics and hygienic-dietetic measures

OTHER

Non antibiotic

Analgesics and hygienic-dietetic measures

Sponsors & Collaborators

  • Monica Mengual Ballester

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06517264 on ClinicalTrials.gov