Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without Antibiotics

NCT06517264 | Enrolling By Invitation

• 1 other identifier: DIVERT-ADIANA
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

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).

Conditions

Diverticulitis, Colonic

Keywords

diverticular disease; uncomplicated diverticulitis; diverticular inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Secondary Outcomes (4)

• Evaluate and contrast the outcomes in terms of recurrence between outpatient treatment with and without antibiotics.

  6 months

• Evaluate and contrast the outcomes in terms of cost-effectiveness between outpatient treatment with and without antibiotics.

  6 months

• Study the risk factors for bad prognosis in patients with uncomplicated diverticulitis

  6 months

• Evaluate the quality of life of these patients after the acute episode and the degree of satisfaction with the treatment received.

  6 months

Other Outcomes (2)

• Complications of diverticulitis

  6 months

• Mortality

  6 moths

Study Arms (2)

Outpatient treatment with antibiotics (group A)

ACTIVE COMPARATOR

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

Outpatient treatment without antibiotics (group B)

OTHER

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

Interventions

Antibiotic DRUG

antibiotic treatment, analgesics and hygienic-dietetic measures

Also known as: Group A

Outpatient treatment with antibiotics (group A)

Non antibiotic OTHER

Analgesics and hygienic-dietetic measures

Also known as: Group B

Outpatient treatment without antibiotics (group B)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Monica Mengual Ballester: lead

Study Sites (1)

Monica Mengual

Murcia, 30007, Spain

Location

Related Publications (13)

• 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.

  PMID: 29679152 RESULT

• 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.

  PMID: 20646266 RESULT

• 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.

  PMID: 33727769 RESULT

• 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.

  PMID: 31352692 RESULT

• 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.

  PMID: 31250244 RESULT

• 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.

  PMID: 32240832 RESULT

• 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.

  PMID: 22290281 RESULT

• 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.

  PMID: 18523784 RESULT

• 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.

  PMID: 32073652 RESULT

• 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.

  PMID: 31485352 RESULT

• 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.

  PMID: 23732265 RESULT

• 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

  RESULT

• 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

  RESULT

MeSH Terms

Conditions

Diverticulitis, Colonic; Diverticular Diseases

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Diverticulitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Diverticulosis, Colonic; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor in Medicine, Specialist in General and Digestive Surgery.

Model Details: Multicenter, controlled, randomized, and open-label study (without blinding) with two treatment arms.

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: November 1, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)