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
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|
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]|
|Actual Enrollment :||2215 participants|
|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|
- Procedure: Colonoscopy
Patients will be submitted to diagnostic colonoscopy
- DICA score and diverticulitis [ Time Frame: 3 years ]Correlation between appearance of diverticulitis and DICA score.
- 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.
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
|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)|