NCT06517264

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

Multicenter Clinical Trial on the Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without Antibiotics Compared to Treatment With Antibiotics. ADIANA TRIAL

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 282 (estimated)
• Sponsor: Monica Mengual Ballester · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The surgeon must reassess the patient at 72 hours, with a complete history of the new clinical status, physical examination, and blood tests (with the same parameters). This visit will check treatment adherence and early clinical response. If the patient shows unfavorable progress or clear clinical deterioration, a new imaging test will be considered, and the assigned therapeutic option will be considered a failure. Follow-up will be completed with a face-to-face consultation one month after the episode and another (face-to-face or telematic) at six months.

Conditions

• Diverticulitis, Colonic

Interventions

Type	Name	Description
DRUG	Antibiotic	antibiotic treatment, analgesics and hygienic-dietetic measures
OTHER	Non antibiotic	Analgesics and hygienic-dietetic measures

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2024-07-24
• Last updated: 2025-02-25

Locations

1 site across 1 country: Spain