A prospective randomised comparison of laparoscopic anterior versus posterior partial fundoplication in patients with gastro-oesophageal reflux disease

ISRCTN	ISRCTN31024562
DOI	https://doi.org/10.1186/ISRCTN31024562
Protocol serial number	N0059103687
Sponsor	Department of Health (UK)
Funder	Sheffield Teaching Hospitals (Central Campus) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Roger Ackroyd
Scientific

STH NHS Trust
General Surgery
K Floor
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom

Phone	+44 (0)114 226 1398
Email	roger.ackroyd@sth.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To prospectively compare laparoscopic anterior versus posterior partial fundoplication in patients with gastro-oesophageal reflux disease.
Ethics approval(s)	Ethics approval received from the South Sheffield Research Ethics Committee
Health condition(s) or problem(s) studied	Gastro-oesophageal reflux disease (GORD)
Intervention	Comparison of laparoscopic anterior versus posterior partial fundoplication.
Intervention type	Other
Primary outcome measure(s)	1. Dysphagia 2. Reflux control
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	30/09/2003

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Key inclusion criteria	100 patients with gastro-oesophageal reflux disease.
Key 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
Date of first enrolment	01/10/2001
Date of final enrolment	30/09/2003

STH NHS Trust

Sheffield
S10 2JF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2010		Yes	No