Evaluation of the Main Determinants of Patient Acceptability of the Bowel Cleansing Procedure, and of Success of Bowel Cleansing and Caecal Intubation

Norgine

Status: Completed

Conditions: Routine Colonoscopy

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01626196

NIT MOV 1002

Details and patient eligibility

About

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).

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

600 participants in 1 patient group

Colonoscopy patients

Description:

Patients undergoing with bowel cleansing procedures according to the clinics' usual routine

Treatment:

Other: No intervention