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

Completed

• Conditions: Routine Colonoscopy
• Interventions: Other: No intervention

• Registration Number: NCT01626196
• Lead Sponsor: Norgine

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-06-21
• Study First Posted: 2012-06-22
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colonoscopy patients	No intervention	Patients undergoing with bowel cleansing procedures according to the clinics' usual routine

Primary Outcome Measures

Name	Time	Method
Patients acceptability of the procedure	One day

Secondary Outcome Measures

Name	Time	Method
Time to reach the caecum	One day
Adenoma detection rate	One day

Trial Locations

Locations (1)

IRCCS Instituto Clinico Humanitas; 🇮🇹 Milan, Rozzano, Italy