Predictive Value of DICA in the Diverticular Disease of the Colon

U

University of Roma La Sapienza

Status

Completed

Conditions

Colonic Diverticula

Treatments

Procedure: Colonoscopy

Study type

Observational

Funder types

Other

Identifiers

NCT02758860
DICA Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,215 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

45

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems