Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0064116181
Study information
Scientific title
Acronym
Study hypothesis
To determine intra-operatively the width and tension of the fundic wrap according to objective criteria. Anti-reflux surgery has to be an effective treatment for gastro-oesophageal reflux disease.
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Gastro-oesophageal reflux disease (GORD)
Intervention
Single centre, patient volunteers, prospective, observational, questionnaire, interview, randomised. Longitudinal, invasive procedures study.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2002
Overall trial end date
03/01/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
40
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2002
Recruitment end date
03/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
City Hospital
Birmingham
B18 7QH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Sandwell and West Birmingham Hospitals NHS Trust - City Hospital (UK)
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