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

This study is currently recruiting participants.

Verified by University Hospital, Geneva, September 2006

Sponsored by:	University Hospital, Geneva
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00160823

Purpose

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.

Condition	Intervention	Phase
Colonoscopy	Procedure: Self-administered leaflet	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

Quality of overall colon cleansing

Secondary Outcome Measures:

Quality of cleansing in the ascending colon,
Frequency of inadequate preparation and of failed procedure,
Time to intubate the caecum,
Cost-effectiveness of the self-administered leaflet,
Patient compliance with the self-administered leaflet,
Patient comfort with the colonoscopy.

Estimated Enrollment:	102
Study Start Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160823

Contacts

Contact: Jean-Marc Dumonceau, MD,PhD	+41223729340	jmdumonceau@hotmail.com
Contact: Jean-Marc Dumonceau	0797645586	jean-Marc.Dumonceau@hcuge.ch

Locations

Switzerland
Gastroenterology and Hepatology Division, University Hospital of Geneva	Recruiting
Geneva, Switzerland, 1205
Contact: Jean-Marc Dumonceau, MD,PhD + 41 22 372 93 40 jmdumonceau@hotmail.com
Principal Investigator: JM Dumonceau, MD,PhD

Sponsors and Collaborators

University Hospital, Geneva

Investigators

Study Chair:

Jean-Marc Dumonceau, MD,PhD

University Hospital of Geneva

More Information

Study ID Numbers:	04-147
Study First Received:	September 8, 2005
Last Updated:	September 11, 2006
ClinicalTrials.gov Identifier:	NCT00160823
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:

Colon cleansing
Quality
Cost-effectiveness

ClinicalTrials.gov processed this record on January 16, 2009