Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without Antibiotics
NCT Number: NCT06517264
Acronym: ADIANA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diverticulitis, Colonic
Interventions: DRUG: Antibiotic|OTHER: Non antibiotic
Sponsor: Monica Mengual Ballester
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 282
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2026-04-30

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).

Primary Outcome Measures: Evaluate the effectiveness and safety of outpatient treatment without antibiotics in patients with uncomplicated diverticulitis, Therapeutic failure is considered when the patient reconsults before 72 hours due to unfavorable progress or clinical deterioration requiring admission., 1 month
Secondary Outcome Measures: Evaluate and contrast the outcomes in terms of recurrence between outpatient treatment with and without antibiotics., recurrence is defined as a new episode of diverticulitis after a period of 12 weeks without symptoms., 6 months|Evaluate and contrast the outcomes in terms of cost-effectiveness between outpatient treatment with and without antibiotics., We reduce the costs derived from antibiotic treatment and its possible side effects with the same cure rates., 6 months|Study the risk factors for bad prognosis in patients with uncomplicated diverticulitis, Study the risk factors for diverticulitis and prognostic factors of therapeutic failure and progression to complicated diverticulitis, 6 months|Evaluate the quality of life of these patients after the acute episode and the degree of satisfaction with the treatment received., It will be assessed with the acute diverticulitis episode-related quality of life test (EuroQol-5D)., 6 months
Other Outcome Measures: Complications of diverticulitis, Complications are considered to be those that require admission of the patient, 6 months|Mortality, death caused by poor evolution of the acute process, 6 moths