An interventional study of Antibiotic and Non antibiotic in Diverticulitis, Colonic, sponsored by Monica Mengual Ballester. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-25.
Sponsored by Monica Mengual Ballester · Not applicable, Interventional, and Treatment
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:
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).
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.
27 studies on the registry are indexed under Diverticulitis, Colonic; 8 are open to participants now.
This study's planned enrollment of 282 is above the median of 142 across 10 interventional studies indexed under Diverticulitis, Colonic.
Browse Diverticulitis, Colonic studies →This is the only study on the registry with Monica Mengual Ballester as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients eligible for hospital admission and/or intravenous antibiotic therapy (at the time of diagnosis).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
antibiotic treatment, analgesics and hygienic-dietetic measures
Also known as: Group A
Analgesics and hygienic-dietetic measures
Also known as: Group B
Evaluate the effectiveness and safety of outpatient treatment without antibiotics in patients with uncomplicated diverticulitis
Therapeutic failure is considered when the patient reconsults before 72 hours due to unfavorable progress or clinical deterioration requiring admission.
Time frame: 1 month
Evaluate and contrast the outcomes in terms of recurrence between outpatient treatment with and without antibiotics.
recurrence is defined as a new episode of diverticulitis after a period of 12 weeks without symptoms.
Time frame: 6 months
Evaluate and contrast the outcomes in terms of cost-effectiveness between outpatient treatment with and without antibiotics.
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 bad prognosis in patients with uncomplicated diverticulitis
Study the risk factors for diverticulitis and prognostic factors of therapeutic failure and progression to complicated diverticulitis
Time frame: 6 months
Evaluate the quality of life of these patients after the acute episode and the degree of satisfaction with the treatment received.
It will be assessed with the acute diverticulitis episode-related quality of life test (EuroQol-5D).
Time frame: 6 months
Complications of diverticulitis
Complications are considered to be those that require admission of the patient
Time frame: 6 months
Mortality
death caused by poor evolution of the acute process
Time frame: 6 moths
Plan to share: No
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