Status:
ENROLLING_BY_INVITATION
Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without Antibiotics
Lead Sponsor:
Monica Mengual Ballester
Conditions:
Diverticulitis, Colonic
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 uncom...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT06517264
Start Date
November 1 2024
End Date
April 30 2026
Last Update
February 25 2025
Active Locations (1)
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1
Monica Mengual
Murcia, Spain, 30007