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Predictive Value of DICA in the Diverticular Disease of the Colon

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment
Colonic Diverticula Procedure: Colonoscopy

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2215 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
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.
Actual Study Start Date : June 2016
Actual Primary Completion Date : September 2020
Actual Study Completion Date : September 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Colonoscopy
    Patients will be submitted to diagnostic colonoscopy


Primary Outcome Measures :
  1. DICA score and diverticulitis [ Time Frame: 3 years ]
    Correlation between appearance of diverticulitis and DICA score.


Secondary Outcome Measures :
  1. DICA score and surgery [ Time Frame: 3 years ]
    Correlation between need to colonic surgery for complicated diverticular disease and DICA score.

  2. DICA score and therapy [ Time Frame: 3 years ]
    Correlation between response to treatment and DICA score.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients accessing the endoscopic service
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758860


Locations
Show Show 45 study locations
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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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)
Additional Information:

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Erasmo Spaziani, Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02758860    
Other Study ID Numbers: DICA Trial
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Erasmo Spaziani, University of Roma La Sapienza:
Colonoscopy
Diverticular disease of the colon
Classification
Additional relevant MeSH terms:
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Diverticular Diseases
Diverticulum
Diverticulum, Colon
Diverticulosis, Colonic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Colonic Diseases
Intestinal Diseases