Comparative study of laparoscopic management of gastro-oesophageal reflux disease by two different surgical methods

ISRCTN	ISRCTN29225711
DOI	https://doi.org/10.1186/ISRCTN29225711
Protocol serial number	N0064116181
Sponsor	Department of Health (UK)
Funder	Sandwell and West Birmingham Hospitals NHS Trust - City Hospital (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Ahmed Hawash
Scientific

City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Gastro-oesophageal reflux disease (GORD)
Intervention	Single centre, patient volunteers, prospective, observational, questionnaire, interview, randomised. Longitudinal, invasive procedures study.
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	03/01/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	40
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/2002
Date of final enrolment	03/01/2007

City Hospital

Birmingham
B18 7QH
United Kingdom

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