Predictive Value of DICA in the Diverticular Disease of the Colon

• ClinicalTrials.gov Identifier: NCT02758860
• Recruitment Status: Completed
• First Posted: May 3, 2016
• Last Update Posted: May 18, 2022
• Sponsor: University of Roma La Sapienza
• Information provided by (Responsible Party): Erasmo Spaziani, University of Roma La Sapienza

Tracking Information

• First Submitted Date: April 23, 2016
• First Posted Date: May 3, 2016
• Last Update Posted Date: May 18, 2022
• Actual Study Start Date: June 2016
• Actual Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 28, 2016)

DICA score and diverticulitis [ Time Frame: 3 years ]

Correlation between appearance of diverticulitis and DICA score.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 28, 2016)

• DICA score and surgery [ Time Frame: 3 years ]
  Correlation between need to colonic surgery for complicated diverticular disease and DICA score.
• DICA score and therapy [ Time Frame: 3 years ]
  Correlation between response to treatment and DICA score.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Predictive Value of DICA in the Diverticular Disease of the Colon
• Official Title: Predictive Value of the Diverticular Inflammation and Complication Assessment (DICA) Endoscopic Classification on the Outcome of the Diverticular Disease of the Colon: a Prospective, Multicenter, International Study.

Brief Summary

The Diverticular Inflammation and Complication Assessment (DICA) is an endoscopic classification for diverticulosis and diverticular disease of the colon.

The aim of the study is to show that DICA classification is a valid parameter to predict the risk of acute diverticulitis occurrence/recurrence and the need of surgery in patients suffering from diverticulosis/diverticular disease of the colon.

Detailed Description

The Diverticular Inflammation and Complication Assessment (DICA) endoscopic classification has been recently developed for patients suffering from diverticulosis and diverticular disease.

A recent multicentre, international, retrospective study found that DICA classification has a significant predictive value on the outcome of the disease in terms of acute diverticulitis occurrence/recurrence and surgery occurrence.

The aim of the present study is to confirm the above mentioned results propectively Several centers, worldwide distributed, will be involved. A minimum of 281 patients will be required for the study. This calculation will be based on the assumption that a continuity-corrected chi-square test with a type I error of 0.05 and a type II error of 0.20 will be expected to detect a difference between a 4.3% prevalence of diverticulitis in patients with diverticulosis and 8.6% in DICA I patients.

Only patients at the first endoscopic diagnosis of diverticulosis/diverticular disease will be enrolled. For each patient, we recorded: age; severity of DICA score; severity of symptoms at entry and during the follow-up; C-reactive protein (CRP) and fecal calprotectin test at the time of diagnosis and during the follow-up (CRP only for DICA 2 and 3 patients); comorbidities (if any); concomitant therapies (if any); therapy taken during the follow-up to maintain remission (if any); months of follow-up; occurrence/recurrence of acute diverticulitis; need of surgery.

The study will take three year. The investigators aim at confirming that DICA classification is a valid parameter to predict the risk of acute diverticulitis occurrence/recurrence and the need of surgery in patients suffering from diverticulosis/diverticular disease of the colon. This could permit to select populations at higher or lower risk, having or not benefit from scheduled (and type) treatment able to reduce those risks.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 3 Years
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Consecutive patients accessing the endoscopic service
• Condition: Colonic Diverticula

Intervention

Procedure: Colonoscopy

Patients will be submitted to diagnostic colonoscopy

• Study Groups/Cohorts: Not Provided

Publications *

• Tursi A, Brandimarte G, Di Mario F, Andreoli A, Annunziata ML, Astegiano M, Bianco MA, Buri L, Cammarota G, Capezzuto E, Chilovi F, Cianci M, Conigliaro R, Del Favero G, Di Cesare L, Di Fonzo M, Elisei W, Faggiani R, Farroni F, Forti G, Germana B, Giorgetti GM, Giovannone M, Lecca PG, Loperfido S, Marmo R, Morucci P, Occhigrossi G, Penna A, Rossi AF, Spadaccini A, Zampaletta C, Zilli M, Zullo A, Scarpignato C, Picchio M. Development and validation of an endoscopic classification of diverticular disease of the colon: the DICA classification. Dig Dis. 2015;33(1):68-76. doi: 10.1159/000366039. Epub 2014 Dec 17.
• Tursi A, Brandimarte G, Di Mario F, Elisei W, Picchio M, Allegretta L, Annunziata ML, Bafutto M, Bassotti G, Bianco MA, Colucci R, Conigliaro R, Dumitrascu D, Escalante R, Ferrini L, Forti G, Franceschi M, Graziani MG, Lammert F, Latella G, Maconi G, Nardone G, Camara de Castro Oliveira L, Chaves Oliveira E, Papa A, Papagrigoriadis S, Pietrzak A, Pontone S, Poskus T, Pranzo G, Reichert MC, Rodino S, Regula J, Scaccianoce G, Scaldaferri F, Vassallo R, Zampaletta C, Zullo A, Piovani D, Bonovas S, Danese S; DICA International Group. Prognostic performance of the 'DICA' endoscopic classification and the 'CODA' score in predicting clinical outcomes of diverticular disease: an international, multicentre, prospective cohort study. Gut. 2022 Jul;71(7):1350-1358. doi: 10.1136/gutjnl-2021-325574. Epub 2021 Oct 26.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 2, 2018): 2215
• Original Estimated Enrollment (submitted: April 28, 2016): 281
• Actual Study Completion Date: September 2020
• Actual Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Endoscopic diagnosis of diverticula in the colon

Exclusion Criteria:

• • Radiological signs (by abdominal CT or by ultrasounds) of acute diverticulitis (complicated or uncomplicated)

  • Inflammatory bowel diseases;
  • Ischemic colitis;
  • Prior colonic resection
  • Patients with severe liver failure (Child-Pugh C);
  • Patients with severe kidney failure;
  • Pregnant women;
  • Women of childbearing potential not using a highly effective method of contraception;
  • Patients who are currently using or who have received any laxative agents < 2 weeks prior to the enrollment;
  • Patients who are currently using or who have received mesalamine compounds < 2 weeks prior to the enrollment;
  • Patients who are currently using or who have received any probiotic agents < 2 weeks prior to the enrollment;
  • Nonsteroidal anti-inflammatory drug (NSAID) use < 1 week prior to the enrollment;
  • Patients who have received treatment with antibiotics (even those not absorbed) < 2 weeks prior to the enrollment;
  • Inability to comply with study protocol and to give informed consensus to the procedure;
  • Patients with or history of cancer, of any origin, within 5 years before enrollment
  • History of alcohol, drug, or chemical abuse
  • Any severe pathological condition that may interfere with the proper study execution.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil, Italy, Lithuania, Poland, Romania, United Kingdom, Venezuela
• Removed Location Countries: Australia, Germany, Hungary, Mexico, Norway, Slovenia, Spain, United States

Administrative Information

• NCT Number: NCT02758860
• Other Study ID Numbers: DICA Trial
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Erasmo Spaziani, University of Roma La Sapienza
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Roma La Sapienza
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Antonio Tursi, MD; Gastroenterology Service , ASL BAT, Andria (BT) - Italy
• Study Director: Giovanni Brandimarte, MD; UOC di Medicina Interna, Servizio di Endoscopia Digestiva, Ospedale "Cristo Re" Rome
• Principal Investigator: Walter Elisei, MD; UOC di Gastroenterologia, ASL Roma 6 Albano Laziale (Rome)
• Principal Investigator: Marcello Picchio, MD; UOC di Chirurgia Generale, Ospedale "P. Colombo", ASL Roma 6 Velletri (Rome)

• PRS Account: University of Roma La Sapienza
• Verification Date: May 2022