Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without An… (NCT06517264) | Clinical Trial Compass
By InvitationNot Applicable
Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without Antibiotics
Spain282 participantsStarted 2024-11-01
Plain-language 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).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 hom…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the effectiveness and safety of outpatient treatment without antibiotics in patients with uncomplicated diverticulitis