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 measure
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 (if study stopped)
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, SNSF, FNS
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
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
Basic results (scientific)
Publication list