Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without Antibiotics
NCT ID: NCT06517264
Last Updated: 2025-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
282 participants
INTERVENTIONAL
2024-11-01
2026-04-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Outpatient treatment with antibiotics (group A)
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.
Antibiotic
antibiotic treatment, analgesics and hygienic-dietetic measures
Outpatient treatment without antibiotics (group B)
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.
Non antibiotic
Analgesics and hygienic-dietetic measures
Interventions
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Antibiotic
antibiotic treatment, analgesics and hygienic-dietetic measures
Non antibiotic
Analgesics and hygienic-dietetic measures
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Monica Mengual Ballester
OTHER
Responsible Party
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Monica Mengual Ballester
Doctor in Medicine, Specialist in General and Digestive Surgery.
Locations
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Monica Mengual
Murcia, , Spain
Countries
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References
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Bolkenstein HE, Draaisma WA, van de Wall B, Consten E, Broeders I. Treatment of acute uncomplicated diverticulitis without antibiotics: risk factors for treatment failure. Int J Colorectal Dis. 2018 Jul;33(7):863-869. doi: 10.1007/s00384-018-3055-1. Epub 2018 Apr 21.
Unlu C, de Korte N, Daniels L, Consten EC, Cuesta MA, Gerhards MF, van Geloven AA, van der Zaag ES, van der Hoeven JA, Klicks R, Cense HA, Roumen RM, Eijsbouts QA, Lange JF, Fockens P, de Borgie CA, Bemelman WA, Reitsma JB, Stockmann HB, Vrouenraets BC, Boermeester MA; Dutch Diverticular Disease 3D Collaborative Study Group. A multicenter randomized clinical trial investigating the cost-effectiveness of treatment strategies with or without antibiotics for uncomplicated acute diverticulitis (DIABOLO trial). BMC Surg. 2010 Jul 20;10:23. doi: 10.1186/1471-2482-10-23.
Hanna MH, Kaiser AM. Update on the management of sigmoid diverticulitis. World J Gastroenterol. 2021 Mar 7;27(9):760-781. doi: 10.3748/wjg.v27.i9.760.
You H, Sweeny A, Cooper ML, Von Papen M, Innes J. The management of diverticulitis: a review of the guidelines. Med J Aust. 2019 Nov;211(9):421-427. doi: 10.5694/mja2.50276. Epub 2019 Jul 28.
Francis NK, Sylla P, Abou-Khalil M, Arolfo S, Berler D, Curtis NJ, Dolejs SC, Garfinkle R, Gorter-Stam M, Hashimoto DA, Hassinger TE, Molenaar CJL, Pucher PH, Schuermans V, Arezzo A, Agresta F, Antoniou SA, Arulampalam T, Boutros M, Bouvy N, Campbell K, Francone T, Haggerty SP, Hedrick TL, Stefanidis D, Truitt MS, Kelly J, Ket H, Dunkin BJ, Pietrabissa A. EAES and SAGES 2018 consensus conference on acute diverticulitis management: evidence-based recommendations for clinical practice. Surg Endosc. 2019 Sep;33(9):2726-2741. doi: 10.1007/s00464-019-06882-z. Epub 2019 Jun 27.
Jaung R, Nisbet S, Gosselink MP, Di Re A, Keane C, Lin A, Milne T, Su'a B, Rajaratnam S, Ctercteko G, Hsee L, Rowbotham D, Hill A, Bissett I. Antibiotics Do Not Reduce Length of Hospital Stay for Uncomplicated Diverticulitis in a Pragmatic Double-Blind Randomized Trial. Clin Gastroenterol Hepatol. 2021 Mar;19(3):503-510.e1. doi: 10.1016/j.cgh.2020.03.049. Epub 2020 Mar 30.
Chabok A, Pahlman L, Hjern F, Haapaniemi S, Smedh K; AVOD Study Group. Randomized clinical trial of antibiotics in acute uncomplicated diverticulitis. Br J Surg. 2012 Apr;99(4):532-9. doi: 10.1002/bjs.8688. Epub 2012 Jan 30.
Lameris W, van Randen A, Bipat S, Bossuyt PM, Boermeester MA, Stoker J. Graded compression ultrasonography and computed tomography in acute colonic diverticulitis: meta-analysis of test accuracy. Eur Radiol. 2008 Nov;18(11):2498-511. doi: 10.1007/s00330-008-1018-6. Epub 2008 Jun 4.
van Dijk ST, Chabok A, Dijkgraaf MG, Boermeester MA, Smedh K. Observational versus antibiotic treatment for uncomplicated diverticulitis: an individual-patient data meta-analysis. Br J Surg. 2020 Jul;107(8):1062-1069. doi: 10.1002/bjs.11465. Epub 2020 Feb 19.
Mari A, Khoury T, Lubany A, Safadi M, Farraj M, Farah A, Kadah A, Sbeit W, Mahamid M. Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios Are Correlated with Complicated Diverticulitis and Hinchey Classification: A Simple Tool to Assess Disease Severity in the Emergency Department. Emerg Med Int. 2019 Aug 14;2019:6321060. doi: 10.1155/2019/6321060. eCollection 2019.
Biondo S, Golda T, Kreisler E, Espin E, Vallribera F, Oteiza F, Codina-Cazador A, Pujadas M, Flor B. Outpatient versus hospitalization management for uncomplicated diverticulitis: a prospective, multicenter randomized clinical trial (DIVER Trial). Ann Surg. 2014 Jan;259(1):38-44. doi: 10.1097/SLA.0b013e3182965a11.
Biondo S, Golda T. Enfermedad diverticular del colon. En: Parrilla P, García-Granero E, Martín E, Morales-Conde S, Navarro S, Targarona EM, editores. Cirugía AEC. 3ª edición. Madrid: Editorial Médica Panamericana, S.A; 2022. p. 547-556
Álvarez C, Arencibia B, Balibrea del Castillo JM, Cerdán C, Dujovne P, Durán V, et al. Monografías de la AEC: Enfermedad Diverticular y Diverticulitis Aguda. Serie nº14. Madrid: Asociación Española de Cirujanos; 2022. p.15-131
Other Identifiers
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DIVERT-ADIANA
Identifier Type: -
Identifier Source: org_study_id
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