Contact information
Type
Scientific
Primary contact
Mr Roger Ackroyd
ORCID ID
Contact details
STH NHS Trust
General Surgery
K Floor
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom
+44 (0)114 226 1398
roger.ackroyd@sth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0059103687
Study information
Scientific title
Acronym
Study hypothesis
To prospectively compare laparoscopic anterior versus posterior partial fundoplication in patients with gastro-oesophageal reflux disease.
Ethics approval
Ethics approval received from the South Sheffield Research Ethics Committee
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
Comparison of laparoscopic anterior versus posterior partial fundoplication.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Dysphagia
2. Reflux control
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/10/2001
Overall trial end date
30/09/2003
Reason abandoned
Eligibility
Participant inclusion criteria
100 patients with gastro-oesophageal reflux disease.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Previous anti-reflux surgery
2. Other concomitant disease being operated at the same time, e.g., gallstones
3. Aged less than 18 or greater than 75 years
Recruitment start date
01/10/2001
Recruitment end date
30/09/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
STH NHS Trust
Sheffield
S10 2JF
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
Sheffield Teaching Hospitals (Central Campus) (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
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20795962
Publication citations
-
Results
Khan M, Smythe A, Globe J, Stoddard CJ, Ackroyd R, Randomized controlled trial of laparoscopic anterior versus posterior fundoplication for gastro-oesophageal reflux disease., ANZ J Surg, 80, 7-8, 500-505, doi: 10.1111/j.1445-2197.2009.05197.x.