Multicentre, Observational, Prospective Study, Conducted on Italian Out-patients Undergoing Colonoscopy, for the Evaluation of the Main Determinants of the Patient's Acceptability of Bowel Cleansing Procedure, and of the Success of Bowel Cleansing and Caecal Intubation

Norgine1 site in 1 country600 target enrollmentFebruary 2012

ConditionsRoutine Colonoscopy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Routine Colonoscopy
Sponsor: Norgine
Enrollment: 600
Locations: 1
Primary Endpoint: Patients acceptability of the procedure
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Several factors are important in achieving a successful colonoscopy, including patient acceptability of the bowel cleansing procedure and the overall quality of cleansing.

This observational study has been designed to explore the main determinants of acceptability of the bowel cleansing procedure to the patient in an Italian "real life" setting. In addition, the study is to examine the determinants of quality of bowel cleansing and describe aspects of the technical performance of the colonoscopy (time to reach the caecum and adenoma detection rate).

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

June 2012

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Norgine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent obtained prior to inclusion.
•Male and female outpatients, aged ≥ 18, treated with bowel cleansing preparation the day before undergoing routine colonoscopy at selected participating centres.

Exclusion Criteria

•Children and adolescents aged less than 18 years. Pregnant or breastfeeding women.
•Listed contra-indications to the relevant product used for the bowel cleansing procedure.
•Patients having been submitted to a previous colonoscopy over the last five years.
•Patients who have taken laxative enemas the day preceding the colonoscopy.