Diverticulitis, Colonic
Conditions
Keywords
diverticular disease, uncomplicated diverticulitis, diverticular inflammation
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 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.
Interventions
DRUGAntibiotic
antibiotic treatment, analgesics and hygienic-dietetic measures
OTHERNon antibiotic
Analgesics and hygienic-dietetic measures
Sponsors
Monica Mengual Ballester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter, controlled, randomized, and open-label study (without blinding) with two treatment arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness and safety of outpatient treatment without antibiotics in patients with uncomplicated diverticulitis | 1 month | Therapeutic failure is considered when the patient reconsults before 72 hours due to unfavorable progress or clinical deterioration requiring admission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate and contrast the outcomes in terms of recurrence between outpatient treatment with and without antibiotics. | 6 months | recurrence is defined as a new episode of diverticulitis after a period of 12 weeks without symptoms. |
| Evaluate and contrast the outcomes in terms of cost-effectiveness between outpatient treatment with and without antibiotics. | 6 months | We reduce the costs derived from antibiotic treatment and its possible side effects with the same cure rates. |
| Study the risk factors for bad prognosis in patients with uncomplicated diverticulitis | 6 months | Study the risk factors for diverticulitis and prognostic factors of therapeutic failure and progression to complicated diverticulitis |
| Evaluate the quality of life of these patients after the acute episode and the degree of satisfaction with the treatment received. | 6 months | It will be assessed with the acute diverticulitis episode-related quality of life test (EuroQol-5D). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complications of diverticulitis | 6 months | Complications are considered to be those that require admission of the patient |
| Mortality | 6 moths | death caused by poor evolution of the acute process |
Countries
Spain
Outcome results
None listed