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Predictive Value of DICA in the Diverticular Disease of the Colon

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ClinicalTrials.gov Identifier: NCT02758860
Recruitment Status : Completed
First Posted : May 3, 2016
Last Update Posted : May 18, 2022
Sponsor:
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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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