Randomized Clinical Trial to Compare the Treatment of Mild Acute Diverticulitis With or Without Antibiotics

Summary

Patients with mild acute diverticulitis (modified Neff 0 grade), following the inclusion criteria and giving informed consent, will be included in the study protocol and will be randomly assigned to one of the treatment arms: symptomatic treatment with NSAID plus antibiotic vs symptomatic treatment with NSAID only. They will be followed-up at 48 hours, 7 days, 30 days and 3 months from the onset of the episode.

Timeline

Start

2016-11

Primary completion

2020-01-12

Completion

2020-04-01

Publications

• Background Strate LL, Modi R, Cohen E, Spiegel BM. Diverticular disease as a chronic illness: evolving epidemiologic and clinical insights. Am J Gastroenterol. 2012 Oct;107(10):1486-93. doi: 10.1038/ajg.2012.194. Epub 2012 Jul 10.
• Background Daniels L, Budding AE, de Korte N, Eck A, Bogaards JA, Stockmann HB, Consten EC, Savelkoul PH, Boermeester MA. Fecal microbiome analysis as a diagnostic test for diverticulitis. Eur J Clin Microbiol Infect Dis. 2014 Nov;33(11):1927-36. doi: 10.1007/s10096-014-2162-3. Epub 2014 Jun 4.
• Background Espin F, Rofes L, Ortega O, Clave P, Gallego D. Nitrergic neuro-muscular transmission is up-regulated in patients with diverticulosis. Neurogastroenterol Motil. 2014 Oct;26(10):1458-68. doi: 10.1111/nmo.12407. Epub 2014 Aug 11.
• Background Humes DJ, Simpson J, Smith J, Sutton P, Zaitoun A, Bush D, Bennett A, Scholefield JH, Spiller RC. Visceral hypersensitivity in symptomatic diverticular disease and the role of neuropeptides and low grade inflammation. Neurogastroenterol Motil. 2012 Apr;24(4):318-e163. doi: 10.1111/j.1365-2982.2011.01863.x. Epub 2012 Jan 25.
• Background 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.
• Background Isacson D, Thorisson A, Andreasson K, Nikberg M, Smedh K, Chabok A. Erratum to: Outpatient, non-antibiotic management in acute uncomplicated diverticulitis: a prospective study. Int J Colorectal Dis. 2015 Sep;30(9):1235. doi: 10.1007/s00384-015-2284-9. No abstract available.
• Background Estrada Ferrer O, Ruiz Edo N, Hidalgo Grau LA, Abadal Prades M, Del Bas Rubia M, Garcia Torralbo EM, Heredia Budo A, Sunol Sala X. Selective non-antibiotic treatment in sigmoid diverticulitis: is it time to change the traditional approach? Tech Coloproctol. 2016 May;20(5):309-315. doi: 10.1007/s10151-016-1464-0. Epub 2016 Apr 6.
• Background Brochmann ND, Schultz JK, Jakobsen GS, Oresland T. Management of acute uncomplicated diverticulitis without antibiotics: a single-centre cohort study. Colorectal Dis. 2016 Nov;18(11):1101-1107. doi: 10.1111/codi.13355.
• Background 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.
• Background Andersen JC, Bundgaard L, Elbrond H, Laurberg S, Walker LR, Stovring J; Danish Surgical Society. Danish national guidelines for treatment of diverticular disease. Dan Med J. 2012 May;59(5):C4453.
• Background Andeweg CS, Mulder IM, Felt-Bersma RJ, Verbon A, van der Wilt GJ, van Goor H, Lange JF, Stoker J, Boermeester MA, Bleichrodt RP; Netherlands Society of Surgery; Working group from Netherlands Societies of Internal Medicine, Gastroenterologists, Radiology, Health echnology Assessment and Dieticians. Guidelines of diagnostics and treatment of acute left-sided colonic diverticulitis. Dig Surg. 2013;30(4-6):278-92. doi: 10.1159/000354035. Epub 2013 Aug 20.
• Background Cuomo R, Barbara G, Pace F, Annese V, Bassotti G, Binda GA, Casetti T, Colecchia A, Festi D, Fiocca R, Laghi A, Maconi G, Nascimbeni R, Scarpignato C, Villanacci V, Annibale B. Italian consensus conference for colonic diverticulosis and diverticular disease. United European Gastroenterol J. 2014 Oct;2(5):413-42. doi: 10.1177/2050640614547068.
• Background Kruis W, Germer CT, Leifeld L; German Society for Gastroenterology, Digestive and Metabolic Diseases and The German Society for General and Visceral Surgery. Diverticular disease: guidelines of the german society for gastroenterology, digestive and metabolic diseases and the german society for general and visceral surgery. Digestion. 2014;90(3):190-207. doi: 10.1159/000367625. Epub 2014 Nov 19.
• Background Mora Lopez L, Serra Pla S, Serra-Aracil X, Ballesteros E, Navarro S. Application of a modified Neff classification to patients with uncomplicated diverticulitis. Colorectal Dis. 2013 Nov;15(11):1442-7. doi: 10.1111/codi.12449.
• Background Alonso S, Pera M, Pares D, Pascual M, Gil MJ, Courtier R, Grande L. Outpatient treatment of patients with uncomplicated acute diverticulitis. Colorectal Dis. 2010 Oct;12(10 Online):e278-82. doi: 10.1111/j.1463-1318.2009.02122.x.
• Background 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.
• Background Gargallo Puyuelo CJ, Sopena F, Lanas Arbeloa A. Colonic diverticular disease. Treatment and prevention. Gastroenterol Hepatol. 2015 Dec;38(10):590-9. doi: 10.1016/j.gastrohep.2015.03.010. Epub 2015 May 12.
• Background Makela JT, Klintrup K, Rautio T. The role of low CRP values in the prediction of the development of acute diverticulitis. Int J Colorectal Dis. 2016 Jan;31(1):23-7. doi: 10.1007/s00384-015-2410-8. Epub 2015 Oct 31.
• Background Makela JT, Klintrup K, Takala H, Rautio T. The role of C-reactive protein in prediction of the severity of acute diverticulitis in an emergency unit. Scand J Gastroenterol. 2015 May;50(5):536-41. doi: 10.3109/00365521.2014.999350. Epub 2015 Feb 9.
• Mora-Lopez L, Ruiz-Edo N, Estrada-Ferrer O, Pinana-Campon ML, Labro-Ciurans M, Escuder-Perez J, Sales-Mallafre R, Rebasa-Cladera P, Navarro-Soto S, Serra-Aracil X; DINAMO-study Group. Efficacy and Safety of Nonantibiotic Outpatient Treatment in Mild Acute Diverticulitis (DINAMO-study): A Multicentre, Randomised, Open-label, Noninferiority Trial. Ann Surg. 2021 Nov 1;274(5):e435-e442. doi: 10.1097/SLA.0000000000005031.
• Mora Lopez L, Ruiz-Edo N, Serra Pla S, Pallisera Llovera A, Navarro Soto S, Serra-Aracil X; Diverticulitis Study Group. Multicentre, controlled, randomized clinical trial to compare the efficacy and safety of ambulatory treatment of mild acute diverticulitis without antibiotics with the standard treatment with antibiotics. Int J Colorectal Dis. 2017 Oct;32(10):1509-1516. doi: 10.1007/s00384-017-2879-4. Epub 2017 Aug 14.

Drugs

Indications