Condition category
Digestive System
Date applied
09/09/2005
Date assigned
25/10/2005
Last edited
14/09/2009
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 Bernard Burnand

ORCID ID

Contact details

IUMSP
Bugnon 17
Lausanne
1005
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The use of an algorithm-based decision to limit access to endoscopy in patients who have an appropriate indication does not modify gastrointestinal (GI) related outcomes.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Upper gastrointestinal symptoms.

Intervention

Patients were randomised to:
A. Decision to perform a gastroscopy supported by information about the appropriateness of the intended decision
B. Decision to perform gastroscopy based on a usual care approach

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. GI symptoms
2. Patient satisfaction
3. Health-related quality of life

Secondary outcome measures

1. Drug for GI symptoms used
2. Absenteeism

Overall trial start date

01/01/1995

Overall trial end date

31/03/1996

Reason abandoned

Eligibility

Participant inclusion criteria

Outpatients suffering upper GI symptoms referred for ambulatory upper GI endoscopy.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Refusal of patients
2. Refusal of physician

Recruitment start date

01/01/1995

Recruitment end date

31/03/1996

Locations

Countries of recruitment

Switzerland

Trial participating centre

IUMSP
Lausanne
1005
Switzerland

Sponsor information

Organisation

University Dept of Medicine and Community Health (Dept Universitaire de Médecine et Santé Communautaires [DUMSC]) (Switzerland)

Sponsor details

Hospices - Centre Hospitalier
Universitaire Vaudois (CHUV)
Rue du Bugnon 44
Lausanne
1011
Switzerland

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

Swiss National Science Foundation,

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

Funder name

SNF 3200-040522.94/1

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

DUMSC, Hospices-CHUV, Lausanne

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