NCT00160823

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

September 13, 2006

Status Verified

September 1, 2006

First QC Date

September 8, 2005

Last Update Submit

September 11, 2006

Conditions

Colonoscopy

Keywords

Colon cleansingQualityCost-effectiveness

Outcome Measures

Primary Outcomes (1)

  • Quality of overall colon cleansing

Secondary Outcomes (6)

  • 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,

  • +1 more secondary outcomes

Interventions

Self-administered leafletPROCEDURE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Total colonoscopy scheduled during hospital stay in the Hôpital Universitaire de Genève (excluding dependencies);
  • Ability to read and write at least one of the following languages : French, English, Spanish, Portuguese.

You may not qualify if:

  • Colonoscopy scheduled under general anesthesia;
  • Occupation inside the healthcare professions;
  • Previous colonoscopy, colostomy or colectomy;
  • Megacolon or idiopathic pseudo-obstruction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology and Hepatology Division, University Hospital of Geneva

Geneva, 1205, Switzerland

RECRUITING

Study Officials

  • Jean-Marc Dumonceau, MD,PhD

    University Hospital, Geneva

    STUDY CHAIR

Central Study Contacts

Jean-Marc Dumonceau, MD,PhD

CONTACT

+41223729340jmdumonceau@hotmail.com

Jean-Marc Dumonceau

CONTACT

0797645586jean-Marc.Dumonceau@hcuge.ch

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2005

Last Updated

September 13, 2006

Record last verified: 2006-09

Locations

CH(1)