Condition category
Digestive System
Date applied
11/02/2008
Date assigned
26/02/2008
Last edited
26/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jean Louis Frossard

ORCID ID

Contact details

Division of Gastroenteorlogy
Geneva University Hospital
Geneve
1211
Switzerland
+41 223 72 93 40
jean-louis.frossard@hcuge.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

001/1999

Study information

Scientific title

Acronym

Study hypothesis

To assess the effectiveness of combined written and oral information, compared with oral information alone on the quality of information before endoscopy and the level of anxiety.

Ethics approval

No ethics approval was required for this trial in 1999. There was no specific ethic committee at the Geneva University Hospital at the time but the trial was approved by the Head of the Division of Gastroenteorlogy.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Other

Patient information sheet

Condition

Gastrointestinal endoscopy

Intervention

Patients randomized either to receiving, along with the appointment notice, an explanatory leaflet about the upcoming examination, or to oral information delivered by each patient's doctor.

The appointment letter was sent to the patient with or without the written information leaflet within one week before endoscopy for most participants. Patient consent to participate was obtained only upon his arrival for the endoscopic procedure.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Evaluation of quality of information rated on scales between 0 (none received) and 5 (excellent), assessed immediately after the endoscopy

Secondary outcome measures

Patients rated the following, using a questionnaire to be filled within 24 hours and sent back by mail in a prepaid envelope:
1. Their anxiety at the time of the procedure (between none and strong)
2. How tolerable the procedure was (between very easy and very hard)
3. Their pain during the procedure (between none and strong)
4. Whether any health problems occurred as a result of the procedure (none, minor, moderate or severe)
5. The procedure as a whole (between poor and excellent)

Overall trial start date

01/01/1999

Overall trial end date

01/04/1999

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients scheduled for an elective digestive endoscopy (upper gastrointestinal endoscopy or colonoscopy) within three months
2. Resident in Switzerland
3. Understand French language
4. Able to fill in the study questionnaire

Note: Both inpatients and outpatients were included

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

800

Participant exclusion criteria

1. Age <18 years
2. Pregnancy
3. Patients unable to give their own consent
4. Patients that had already undergone prior endoscopy

Recruitment start date

01/01/1999

Recruitment end date

01/04/1999

Locations

Countries of recruitment

Switzerland

Trial participating centre

Division of Gastroenteorlogy
Geneve
1211
Switzerland

Sponsor information

Organisation

Geneva University Hospital (Switzerland)

Sponsor details

Rue Micheli du Crest
Geneve
1211
Switzerland
+41 22 372 93 40
jean-louis.frossard@hcuge.ch

Sponsor type

Hospital/treatment centre

Website

http://www.hug-ge.ch

Funders

Funder type

Hospital/treatment centre

Funder name

This trial was internally funded by the Geneva University Hospital (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes