Predictive Value of DICA in the Diverticular Disease of the Colon

Study Overview
=================
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.

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.

Conditions
-----------------
Colonic Diverticula

Intervention / Treatment
-----------------
* Procedure: Colonoscopy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Colonoscopy|Patients will be submitted to diagnostic colonoscopy|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DICA score and diverticulitis | Correlation between appearance of diverticulitis and DICA score. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DICA score and surgery | Correlation between need to colonic surgery for complicated diverticular disease and DICA score. | 3 years | 
| DICA score and therapy | Correlation between response to treatment and DICA score. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonoscopy, Diverticular disease of the colon, Classification