Randomized Multicentric Trial to Evaluate a Free Diet With a Progressive Diet in the Treatment of Acute Diverticulitis (DIVERDIET)

NCT03496090 | Completed

• 1 other identifier: DIVERDIET
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

Phase III trial is designed to demonstrate the non-inferiority of a free diet versus a progressive diet in the treatment of acute diverticulitis (AD) without complications. In this study, the effectiveness of the short-term free diet is evaluated, as well as its safety and the quality of life that is perceived in front of the progressive diet.

Conditions

Diverticulitis; Acute Diverticulitis; Diverticulitis, Colonic; Uncomplicated Diverticular Disease; Diverticulitis of Sigmoid; Diet Modification; Dietary Modification

Keywords

Diverticulitis; Uncomplicated Diverticular Disease; Free diet; Dietary restriction; Acute Diverticulitis

Outcome Measures

Primary Outcomes (1)

• Success in the treatment

  Absence of persistence, increase or recurrence of abdominal pain or fever, transition to a stage higher than that of the modified Hinchey classification (requiring radiological drainage and / or surgical treatment), need for hospital admission (for outpatients) and death attributed to this diagnosis.

  30 days

Secondary Outcomes (5)

• Pain score

  7 days

• Body temperature

  7 days

• PCR value

  day 0, 3 and 7

• Increase in stage

  30 days

• Need for hospital admission

  30 days

Study Arms (2)

Free diet

EXPERIMENTAL

Free diet or free demand, being comparable to the normal or zero hospital diet

Other: Free diet

Progressive diet

ACTIVE COMPARATOR

Progressive diet for 7 days, liquid diet for the first three days and soft diet without waste, from the 4th to the 7th day.

Other: Progressive diet

Interventions

Free diet OTHER

Free diet or free demand, being comparable to the normal or zero hospital diet

Also known as: Basal diet

Free diet

Progressive diet OTHER

Progressive diet for 7 days, liquid diet for the first three days and soft diet without waste, from the 4th to the 7th day.

Progressive diet

Eligibility Criteria

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

You may qualify if:

• Diagnosis of uncomplicated acute diverticulitis
• Adequate oral tolerance
• Good response to the first emergency treatment measures (analgesics and antibiotic therapy): improvement of pain and decrease in temperature.
• Willing to continue treatment at home under supervision.
• Accept sign informed consent.

You may not qualify if:

• Acute complicated diverticulitis (from grade Ib of the modified Hinchey Classification).
• No good response to the first emergency treatment measures (analgesics and antibiotics): maintenance or increase of abdominal pain, persistence of fever, oral intolerance or vomiting, clinical worsening.
• Antibiotic treatment for diverticulitis in the previous month.
• Suspicion of colorectal cancer.
• Pregnant.
• Refuses to sign informed consent.

Sponsors & Collaborators

• Hospital General Universitario Reina Sofía de Murcia: lead

Study Sites (1)

Hospital General Universitario Reina Sofía

Murcia, 30003, Spain

Location

Related Publications (41)

• Tursi A, Elisei W, Brandimarte G, Giorgetti GM, Aiello F. Predictive value of serologic markers of degree of histologic damage in acute uncomplicated colonic diverticulitis. J Clin Gastroenterol. 2010 Nov-Dec;44(10):702-6. doi: 10.1097/MCG.0b013e3181dad979.

  PMID: 20485187 BACKGROUND

• Klarenbeek BR, de Korte N, van der Peet DL, Cuesta MA. Review of current classifications for diverticular disease and a translation into clinical practice. Int J Colorectal Dis. 2012 Feb;27(2):207-14. doi: 10.1007/s00384-011-1314-5. Epub 2011 Sep 17.

  PMID: 21928041 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

• Reynolds IS, Heaney RM, Khan W, Khan IZ, Waldron R, Barry K. The Utility of Neutrophil to Lymphocyte Ratio as a Predictor of Intervention in Acute Diverticulitis. Dig Surg. 2017;34(3):227-232. doi: 10.1159/000450836. Epub 2016 Dec 10.

  PMID: 27941316 RESULT

• 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.

  PMID: 25665622 RESULT

• van de Wall BJ, Draaisma WA, van der Kaaij RT, Consten EC, Wiezer MJ, Broeders IA. The value of inflammation markers and body temperature in acute diverticulitis. Colorectal Dis. 2013 May;15(5):621-6. doi: 10.1111/codi.12072.

  PMID: 23088216 RESULT

• Nizri E, Spring S, Ben-Yehuda A, Khatib M, Klausner J, Greenberg R. C-reactive protein as a marker of complicated diverticulitis in patients on anti-inflammatory medications. Tech Coloproctol. 2014 Feb;18(2):145-9. doi: 10.1007/s10151-013-1044-5. Epub 2013 Jun 27.

  PMID: 23807310 RESULT

• Ferzoco LB, Raptopoulos V, Silen W. Acute diverticulitis. N Engl J Med. 1998 May 21;338(21):1521-6. doi: 10.1056/NEJM199805213382107. No abstract available.

  PMID: 9593792 RESULT

• Jackson JD, Hammond T. Systematic review: outpatient management of acute uncomplicated diverticulitis. Int J Colorectal Dis. 2014 Jul;29(7):775-81. doi: 10.1007/s00384-014-1900-4. Epub 2014 May 25.

  PMID: 24859874 RESULT

• Martin Gil J, Serralta De Colsa D, Garcia Marin A, Vaquero Rodriguez A, Rey Valcarcel C, Perez Diaz MD, Sanz Sanchez M, Turegano Fuentes F. [Safety and efficiency of ambulatory treatment of acute diverticulitis]. Gastroenterol Hepatol. 2009 Feb;32(2):83-7. doi: 10.1016/j.gastrohep.2008.10.005. Epub 2009 Feb 5. Spanish.

  PMID: 19231679 RESULT

• Rosado-Cobian R, Blasco-Segura T, Ferrer-Marquez M, Marin-Ortega H, Perez-Dominguez L, Biondo S, Roig-Vila JV. Complicated diverticular disease: Position statement on outpatient management, Hartmann's procedure, laparoscopic peritoneal lavage and laparoscopic approach. Consensus document of the Spanish Association of Coloproctology and the Coloproctology Section of the Spanish Association of Surgeons. Cir Esp. 2017 Aug-Sep;95(7):369-377. doi: 10.1016/j.ciresp.2017.03.008. Epub 2017 Apr 14. English, Spanish.

  PMID: 28416357 RESULT

• Pelaez N, Pera M, Courtier R, Sanchez J, Gil MJ, Pares D, Grandea L. [Applicability, safety and efficacy of an ambulatory treatment protocol in patients with uncomplicated acute diverticulitis]. Cir Esp. 2006 Dec;80(6):369-72. doi: 10.1016/s0009-739x(06)70989-7. Spanish.

  PMID: 17192220 RESULT

• Moya P, Arroyo A, Perez-Legaz J, Serrano P, Candela F, Soriano-Irigaray L, Calpena R. Applicability, safety and efficiency of outpatient treatment in uncomplicated diverticulitis. Tech Coloproctol. 2012 Aug;16(4):301-7. doi: 10.1007/s10151-012-0847-0. Epub 2012 Jun 16.

  PMID: 22706731 RESULT

• Mizuki A, Nagata H, Tatemichi M, Kaneda S, Tsukada N, Ishii H, Hibi T. The out-patient management of patients with acute mild-to-moderate colonic diverticulitis. Aliment Pharmacol Ther. 2005 Apr 1;21(7):889-97. doi: 10.1111/j.1365-2036.2005.02422.x.

  PMID: 15801924 RESULT

• Isacson D, Thorisson A, Andreasson K, Nikberg M, Smedh K, Chabok A. Outpatient, non-antibiotic management in acute uncomplicated diverticulitis: a prospective study. Int J Colorectal Dis. 2015 Sep;30(9):1229-34. doi: 10.1007/s00384-015-2258-y. Epub 2015 May 20.

  PMID: 25989930 RESULT

• Etzioni DA, Chiu VY, Cannom RR, Burchette RJ, Haigh PI, Abbas MA. Outpatient treatment of acute diverticulitis: rates and predictors of failure. Dis Colon Rectum. 2010 Jun;53(6):861-5. doi: 10.1007/DCR.0b013e3181cdb243.

  PMID: 20484998 RESULT

• van Dijk ST, Rottier SJ, van Geloven AAW, Boermeester MA. Conservative Treatment of Acute Colonic Diverticulitis. Curr Infect Dis Rep. 2017 Sep 23;19(11):44. doi: 10.1007/s11908-017-0600-y.

  PMID: 28942590 RESULT

• Vennix S, Morton DG, Hahnloser D, Lange JF, Bemelman WA; Research Committee of the European Society of Coloproctocology. Systematic review of evidence and consensus on diverticulitis: an analysis of national and international guidelines. Colorectal Dis. 2014 Nov;16(11):866-78. doi: 10.1111/codi.12659.

  PMID: 24801825 RESULT

• Stollman N, Smalley W, Hirano I; AGA Institute Clinical Guidelines Committee. American Gastroenterological Association Institute Guideline on the Management of Acute Diverticulitis. Gastroenterology. 2015 Dec;149(7):1944-9. doi: 10.1053/j.gastro.2015.10.003. Epub 2015 Oct 8. No abstract available.

  PMID: 26453777 RESULT

• Binda GA, Cuomo R, Laghi A, Nascimbeni R, Serventi A, Bellini D, Gervaz P, Annibale B; Italian Society of Colon and Rectal Surgery. Practice parameters for the treatment of colonic diverticular disease: Italian Society of Colon and Rectal Surgery (SICCR) guidelines. Tech Coloproctol. 2015 Oct;19(10):615-26. doi: 10.1007/s10151-015-1370-x. Epub 2015 Sep 16.

  PMID: 26377584 RESULT

• 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.

  PMID: 23969324 RESULT

• Feingold D, Steele SR, Lee S, Kaiser A, Boushey R, Buie WD, Rafferty JF. Practice parameters for the treatment of sigmoid diverticulitis. Dis Colon Rectum. 2014 Mar;57(3):284-94. doi: 10.1097/DCR.0000000000000075. No abstract available.

  PMID: 24509449 RESULT

• Stam MA, Draaisma WA, van de Wall BJ, Bolkenstein HE, Consten EC, Broeders IA. An unrestricted diet for uncomplicated diverticulitis is safe: results of a prospective diverticulitis diet study. Colorectal Dis. 2017 Apr;19(4):372-377. doi: 10.1111/codi.13505.

  PMID: 27611011 RESULT

• van de Wall BJ, Draaisma WA, van Iersel JJ, van der Kaaij R, Consten EC, Broeders IA. Dietary restrictions for acute diverticulitis: evidence-based or expert opinion? Int J Colorectal Dis. 2013 Sep;28(9):1287-93. doi: 10.1007/s00384-013-1694-9. Epub 2013 Apr 19.

  PMID: 23604409 RESULT

• 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.

  PMID: 22549495 RESULT

• Sartelli M, Catena F, Ansaloni L, Coccolini F, Griffiths EA, Abu-Zidan FM, Di Saverio S, Ulrych J, Kluger Y, Ben-Ishay O, Moore FA, Ivatury RR, Coimbra R, Peitzman AB, Leppaniemi A, Fraga GP, Maier RV, Chiara O, Kashuk J, Sakakushev B, Weber DG, Latifi R, Biffl W, Bala M, Karamarkovic A, Inaba K, Ordonez CA, Hecker A, Augustin G, Demetrashvili Z, Melo RB, Marwah S, Zachariah SK, Shelat VG, McFarlane M, Rems M, Gomes CA, Faro MP, Junior GA, Negoi I, Cui Y, Sato N, Vereczkei A, Bellanova G, Birindelli A, Di Carlo I, Kok KY, Gachabayov M, Gkiokas G, Bouliaris K, Colak E, Isik A, Rios-Cruz D, Soto R, Moore EE. WSES Guidelines for the management of acute left sided colonic diverticulitis in the emergency setting. World J Emerg Surg. 2016 Jul 29;11:37. doi: 10.1186/s13017-016-0095-0. eCollection 2016.

  PMID: 27478494 RESULT

• 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.

  PMID: 25413249 RESULT

• Biondo S, Lopez Borao J, Millan M, Kreisler E, Jaurrieta E. Current status of the treatment of acute colonic diverticulitis: a systematic review. Colorectal Dis. 2012 Jan;14(1):e1-e11. doi: 10.1111/j.1463-1318.2011.02766.x.

  PMID: 21848896 RESULT

• Boermeester MA, Humes DJ, Velmahos GC, Soreide K. Contemporary Review of Risk-Stratified Management in Acute Uncomplicated and Complicated Diverticulitis. World J Surg. 2016 Oct;40(10):2537-45. doi: 10.1007/s00268-016-3560-8.

  PMID: 27206400 RESULT

• Bugiantella W, Rondelli F, Longaroni M, Mariani E, Sanguinetti A, Avenia N. Left colon acute diverticulitis: an update on diagnosis, treatment and prevention. Int J Surg. 2015 Jan;13:157-164. doi: 10.1016/j.ijsu.2014.12.012. Epub 2014 Dec 11.

  PMID: 25497007 RESULT

• Balasubramanian I, Fleming C, Mohan HM, Schmidt K, Haglind E, Winter DC. Out-Patient Management of Mild or Uncomplicated Diverticulitis: A Systematic Review. Dig Surg. 2017;34(2):151-160. doi: 10.1159/000450865. Epub 2016 Oct 5.

  PMID: 27701164 RESULT

• Morris AM, Regenbogen SE, Hardiman KM, Hendren S. Sigmoid diverticulitis: a systematic review. JAMA. 2014 Jan 15;311(3):287-97. doi: 10.1001/jama.2013.282025.

  PMID: 24430321 RESULT

• Medina-Fernandez FJ, Diaz-Jimenez N, Gallardo-Herrera AB, Gomez-Luque I, Garcilazo-Arsimendi DJ, Gomez-Barbadillo J. New trends in the management of diverticulitis and colonic diverticular disease. Rev Esp Enferm Dig. 2015 Mar;107(3):162-70.

  PMID: 25733040 RESULT

• Park HC, Kim BS, Lee BH. Management of right colonic uncomplicated diverticulitis: outpatient versus inpatient management. World J Surg. 2011 May;35(5):1118-22. doi: 10.1007/s00268-011-1048-0.

  PMID: 21409607 RESULT

• Diez Buron F, Marcos Vidal JM, Baticon Escudero PM, Montes Armenteros A, Bermejo Lopez JC, Merino Garcia M. [Agreement between verbal numerical scale and visual analog scale assessments in monitoring acute postoperative pain]. Rev Esp Anestesiol Reanim. 2011 May;58(5):279-82. doi: 10.1016/s0034-9356(11)70062-7. Spanish.

  PMID: 21688506 RESULT

• Vilagut G, Ferrer M, Rajmil L, Rebollo P, Permanyer-Miralda G, Quintana JM, Santed R, Valderas JM, Ribera A, Domingo-Salvany A, Alonso J. [The Spanish version of the Short Form 36 Health Survey: a decade of experience and new developments]. Gac Sanit. 2005 Mar-Apr;19(2):135-50. doi: 10.1157/13074369. Spanish.

  PMID: 15860162 RESULT

• Alonso J, Regidor E, Barrio G, Prieto L, Rodriguez C, de la Fuente L. [Population reference values of the Spanish version of the Health Questionnaire SF-36]. Med Clin (Barc). 1998 Oct 10;111(11):410-6. Spanish.

  PMID: 9834913 RESULT

• Schmidt S, Vilagut G, Garin O, Cunillera O, Tresserras R, Brugulat P, Mompart A, Medina A, Ferrer M, Alonso J. [Reference guidelines for the 12-Item Short-Form Health Survey version 2 based on the Catalan general population]. Med Clin (Barc). 2012 Dec 8;139(14):613-25. doi: 10.1016/j.medcli.2011.10.024. Epub 2012 Jan 11. Spanish.

  PMID: 22244683 RESULT

• Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

  PMID: 8628042 RESULT

• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

  PMID: 1593914 RESULT

• Garratt A, Schmidt L, Mackintosh A, Fitzpatrick R. Quality of life measurement: bibliographic study of patient assessed health outcome measures. BMJ. 2002 Jun 15;324(7351):1417. doi: 10.1136/bmj.324.7351.1417.

  PMID: 12065262 RESULT

Related Links

• hospital diets
• Diverticular Disease: An Update on Pathogenesis and Management. Gut Liver

MeSH Terms

Conditions

Diverticulitis; Diverticulitis, Colonic

Interventions

Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jorge A Benavides Buleje, Dr.

  Hospital General Universitario Reina Sofía de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient data will be delivered to the investigator/s of the study of each hospital, who will fill out the Data Collection Notebook (DCN) of each patient and program their controls without information of the group to which the patient has been assigned, as such In this way, the consultations are carried out with blinding of the evaluator (the investigator who will do the controls will not know to which group the patient has been assigned). The person in charge of carrying out the statistical analysis will not be able to know to which group the patient has been assigned due to the coding done in the DCN.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a randomized, multicentric, controlled with active comparator, parallel group, blind to the evaluator, to demonstrate the non-inferiority in the efficacy and therapeutic and safety of the free diet (group 1) compared to the progressive diet (group 2) in the treatment of uncomplicated acute diverticulitis. This study will be carried out on 134 patients with uncomlpicated acute diverticulitis. The subjects will be randomized in a 1: 1 ratio to receive treatment with progressive diet or diet at free demand. The main analysis will take place two months after the start of treatment.

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 12, 2018
• Study Start: April 16, 2018
• Primary Completion: January 31, 2019
• Study Completion: April 16, 2019
• Last Updated: August 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)