Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital Patients

Colonoscopy Clinical Trial

Official title:

Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00160823
• Other study ID #: 04-147
• Status: Recruiting
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: September 11, 2006
• Start date: September 2005

Study information

• Verified date: September 2006
• Source: University Hospital, Geneva
• Contact: Jean-Marc Dumonceau, MD,PhD
• Phone: +41223729340
• Email: jmdumonceau[@]hotmail.com
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

The quality of colon cleansing has a major impact on efficiency and cost of colonoscopy. A hand-out was made to instruct and motivate patients to adequately clean the bowel before colonoscopy.

The aim of the study is to compare adequacy of bowel cleansing in hospitalized patients receiving the hand-out or not on the day before colonoscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Total colonoscopy scheduled during hospital stay in the Hôpital Universitaire de Genève (excluding dependencies);

• Informed consent for inclusion in the study signed by the patient;

• Ability to read and write at least one of the following languages : French, English, Spanish, Portuguese.

Exclusion Criteria:

• Colonoscopy scheduled under general anesthesia;

• Occupation inside the healthcare professions;

• Previous colonoscopy, colostomy or colectomy;

• Megacolon or idiopathic pseudo-obstruction.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Procedure:
• Self-administered leaflet

Locations

Country	Name	City	State
Switzerland	Gastroenterology and Hepatology Division, University Hospital of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of overall colon cleansing
Secondary	Quality of cleansing in the ascending colon,
Secondary	Frequency of inadequate preparation and of failed procedure,
Secondary	Time to intubate the caecum,
Secondary	Cost-effectiveness of the self-administered leaflet,
Secondary	Patient compliance with the self-administered leaflet,
Secondary	Patient comfort with the colonoscopy.