Routine Colonoscopy Clinical Trial
Official title:
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
| Verified date | July 2012 |
| Source | Norgine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ministry of Health |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 600 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Ecologic or Community, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | IRCCS Instituto Clinico Humanitas | Milan | Rozzano |
| Lead Sponsor | Collaborator |
|---|---|
| Norgine |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patients acceptability of the procedure | One day | No | |
| Secondary | Time to reach the caecum | One day | No | |
| Secondary | Adenoma detection rate | One day | No |