Impact of a Self-Administered Information Leaflet on Adeq... | NCT00160823

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

NCT00160823

Sponsor

University Hospital, Geneva

Status

Unknown status

Last Update Posted

Sep 13, 2006Estimated

Enrollment

102

Phase

Phase 3

Conditions

Colonoscopy

Interventions

Self-administered leaflet

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2006

Last Update Posted Date

Sep 13, 2006Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102

Name	Type	Description	Arm Group Labels	Other Names
Self-administered leaflet	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of overall colon cleansing

Secondary Outcomes

Measure	Description	Time Frame
Quality of cleansing in the ascending colon,
Frequency of inadequate preparation and of failed procedure,
Time to intubate the caecum,

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jean-Marc Dumonceau, MD,PhD	Contact	+41223729340		jmdumonceau@hotmail.com
Jean-Marc Dumonceau	Contact	0797645586		jean-Marc.Dumonceau@hcuge.ch

Overall Officials

Name	Affiliation	Role
Jean-Marc Dumonceau, MD,PhD	University Hospital, Geneva	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gastroenterology and Hepatology Division, University Hospital of Geneva	Recruiting	Geneva		1205	Switzerland