Monica Mengual
Murcia, 30007, Spain
NCT Number: NCT06517264
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).
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Murcia, 30007, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
antibiotic treatment, analgesics and hygienic-dietetic measures
Other names: Group A
Analgesics and hygienic-dietetic measures
Other names: Group B
Time frame: 1 month
Therapeutic failure is considered when the patient reconsults before 72 hours due to unfavorable progress or clinical deterioration requiring admission.
Time frame: 6 months
recurrence is defined as a new episode of diverticulitis after a period of 12 weeks without symptoms.
Time frame: 6 months
We reduce the costs derived from antibiotic treatment and its possible side effects with the same cure rates.
Time frame: 6 months
Study the risk factors for diverticulitis and prognostic factors of therapeutic failure and progression to complicated diverticulitis
Time frame: 6 months
It will be assessed with the acute diverticulitis episode-related quality of life test (EuroQol-5D).
Time frame: 6 months
Complications are considered to be those that require admission of the patient
Time frame: 6 moths
death caused by poor evolution of the acute process
Monica Mengual Ballester
Other
Multicenter Clinical Trial on the Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without Antibiotics Compared to Treatment With Antibiotics. ADIANA TRIAL
Acronym: ADIANA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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