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

September 11, 2006 updated by: University Hospital, Geneva

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

102

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • Recruiting
        • Gastroenterology and Hepatology Division, University Hospital of Geneva
        • Contact:
        • Principal Investigator:
          • JM Dumonceau, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Quality of overall colon cleansing

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Study Chair: Jean-Marc Dumonceau, MD,PhD, University Hospital, Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

September 13, 2006

Last Update Submitted That Met QC Criteria

September 11, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 04-147

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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