Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without Antibiotics (ADIANA)

February 22, 2025 updated by: Monica Mengual Ballester

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

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).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

282

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30007
        • Monica Mengual

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients over 18 years old with clinical and radiological diagnosis of acute sigmoid or descending colon diverticulitis (left-sided acute diverticulitis) not complicated.
  • Radiological diagnosis of acute uncomplicated diverticulitis by CT (Modified Hinchey Classification 0-Ia).
  • First episode or previous history of acute diverticulitis (both complicated and uncomplicated), with ≥6 months between the last episode and the current clinical presentation).
  • Informed consent to participate in the study.

Exclusion Criteria:

  • Age >80 years.

  • Patients eligible for hospital admission and/or intravenous antibiotic therapy (at the time of diagnosis).

    • Repeated vomiting or oral intolerance.
    • Need for intravenous fluid therapy and/or close monitoring.
    • Peripheral body temperature >38ºC.
    • Deterioration of general condition and/or clinical suspicion of sepsis.
  • Significant or decompensated comorbidity: ASA IV Classification (anesthetic risk of American Society of Anesthesiologists).
  • Immunocompromised patients: Hematological cause, HIV with low CD4+ levels, immunosuppressive treatment, prolonged corticosteroid therapy, chemotherapy, transplanted or splenectomized patients, predisposing genetic alterations (severe combined immunodeficiency, etc.).
  • Oral or intravenous antibiotic therapy 2 weeks before the onset of symptoms for another cause.
  • Pregnancy.
  • Inflammatory bowel disease (Crohn's disease, ulcerative colitis).
  • Lack of social and home support making outpatient treatment and follow-up impossible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Outpatient treatment without antibiotics (group B)

Hygienic-dietary measures:

  • Low-residue diet for the first 48 hours. An informative leaflet will be provided to clarify these recommendations.
  • Adequate oral hydration during the episode.
  • Paracetamol 1 gram orally, one tablet every 8 hours. If pain persists, alternate every 4 hours Paracetamol with Metamizole 575 mg, one tablet every 8 hours. If allergic to Metamizole, it can be substituted with Dexketoprofen 25 mg, one tablet every 8 hours.
Other: Non antibiotic
Analgesics and hygienic-dietetic measures
Other Names:
  • Group B
Active Comparator: Outpatient treatment with antibiotics (group A)

If belonging to group A (receiving oral antibiotic therapy), the usual oral antibiotic regimen of each center will be indicated.

According to according to the guidelines of our hospital:

  • 3rd generation cephalosporin (e.g., Cefditoren 200 mg, one tablet every 12 hours) + Metronidazole 500 mg, two tablets every 8 hours. Duration of treatment: 7 days.
  • Penicillin allergy: Ciprofloxacin 500 mg, one tablet every 12 hours + Metronidazole 500 mg, two tablets every 8 hours. Duration of treatment: 7 days.

Hygienic-dietary measures:

  • Low-residue diet for the first 48 hours. An informative leaflet will be provided to clarify these recommendations.
  • Adequate oral hydration during the episode.
  • Paracetamol 1 gram orally, one tablet every 8 hours. If pain persists, alternate every 4 hours Paracetamol with Metamizole 575 mg, one tablet every 8 hours. If allergic to Metamizole, it can be substituted with Dexketoprofen 25 mg, one tablet every 8 hours.
Drug: Antibiotic
antibiotic treatment, analgesics and hygienic-dietetic measures
Other Names:
  • Group A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effectiveness and safety of outpatient treatment without antibiotics in patients with uncomplicated diverticulitis
Time Frame: 1 month
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

Outcome Measure
Measure Description
Time Frame
Evaluate and contrast the outcomes in terms of recurrence between outpatient treatment with and without antibiotics.
Time Frame: 6 months
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.
Time Frame: 6 months
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
Time Frame: 6 months
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.
Time Frame: 6 months
It will be assessed with the acute diverticulitis episode-related quality of life test (EuroQol-5D).
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications of diverticulitis
Time Frame: 6 months
Complications are considered to be those that require admission of the patient
6 months
Mortality
Time Frame: 6 moths
death caused by poor evolution of the acute process
6 moths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monica Mengual Ballester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

July 18, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 22, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIVERT-ADIANA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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