The place of minimal access surgery amongst people with gastro-oesophageal reflux disease (GORD) - a UK collaborative study

ISRCTN	ISRCTN15517081
DOI	https://doi.org/10.1186/ISRCTN15517081
Protocol serial number	HTA 97/10/03
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 24/02/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Adrian Grant
Scientific

Health Services Research Unit
University of Aberdeen
Polwarth Building
Foresterhill
Aberdeen
AB9 2ZD
United Kingdom

Phone	+44 (0)1224 553908
Email	a.grant@adn.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	REFLUX
Study objectives	Study hypothesis amended as of 09/08/2007 (Please note that these amendments reflect errors in information provided at time of registration): 1. To evaluate the clinical effectiveness, cost-effectiveness, and safety of a policy of relatively early laparoscopic surgery compared with continued medical management amongst people with Gastro-Oesophageal Reflux Disease (GORD) judged suitable for both policies. 2. To explore factors which may influence the relative performance of the two policies, such as patient preference, surgeon experience, pre-enrolment symptoms and signs, the underlying pathology, the type of operative procedure used or choice of therapy, and the time since surgery. 3. To explore the impact that various policies for using laparoscopic surgery would have on the NHS and society. Multi-centre, pragmatic randomised trial (with parallel, non-randomised preference groups), Economic evaluation. Setting: Secondary care provided by gastro-enterologists and surgeons. Previous study hypothesis: 1. To evaluate the clinical effectiveness, cost-effectiveness, and safety of a policy of relatively early laparoscopic surgery compared with continued medical management amongst people with gastro-oesophageal reflux disease (GORD) judged suitable for both policies. 2. To explore factors which may influence the relative performance of the two policies, such as patient preference, surgeon experience, pre-enrolment symptoms and signs, the underlying pathology, the type of operative procedure used or choice of therapy, and the time since surgery. 3. To identify the proportion and number of patients with GORD managed within the NHS for whom laparoscopic surgery could be recommended. 4. To explore the impact that various policies for using laparoscopic surgery would have on the NHS and society. Multi-centre, pragmatic randomised trial (with parallel, non-randomised preference groups), Primary care based descriptive population study, Economic evaluation. Setting: (A) Secondary care provided by gastro-enterologists and surgeons (B) General practice (C) Combination of (A) and (B). More details can be found at http://www.hta.ac.uk/1134 Please note that, as of 09/08/2007, the target number of participants has been amended from 357 to 810. Please note that, as of 11/01/2008, the anticipated start and end dates of this trial have been updated from 01/10/1999 and 31/05/2011 to 01/06/2000 and 30/09/2006, respectively. The anticipated end date of this trial provided at time of registration was 30/09/2004. An extended follow-up study of this trial started in May 2007 (HTA ref: 97/10/99).
Ethics approval(s)	Approved by Medical Research Ethics Committee for Scotland and Local Research Ethics Committees.
Health condition(s) or problem(s) studied	Gastro-oesophageal reflux disease
Intervention	Laparoscopic surgery vs continued medical management
Intervention type	Other
Primary outcome measure(s)	Primary outcome measures amended as of 09/08/2007: Cost and outcome measurement (assessed through annual questionnaires): 1. Primary: disease-specific quality of life, health-related quality of life (the EuroQoL [EQ-5D] questionnaire and the 12-item Short Form health survey [SF-12]) and NHS costs. 2. Treatment preferences and attitudes to surgery and medical management. 3. Indices of differential cost effectiveness with economic modelling. Previous primary outcome measures: Cost and outcome measurement: 1. Primary - NHS costs and health-related quality of life (EQ5D and SF12) secondary - patient costs, disease specific HRQL, treatment changes, side effects and complications. 2. Prevalence PPI for GORD (>12 months); treatment preferences and attitude to surgery. 3. Indices of differential cost effectiveness and economic models of NHS uptake of minimal access surgery.
Key secondary outcome measure(s)	Added as of 09/08/2007: The following are assessed through annual questionnaires: 1. Patient costs 2. Treatment changes 3. Side effects and complications
Completion date	30/09/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	810
Key inclusion criteria	Inclusion criteria amended as of 09/08/2007 (Please note that these amendments reflect errors in information provided at time of registration): Long-term proton pump inhibitor (PPI)-treated GORD patients suitable for surgical or medical secondary care management Previous inclusion criteria: 1. Long-term proton pump inhibitor (PPI)-treated GORD patients suitable for surgical or medical secondary care management 2. All PPI treated GORD patients in General Practice
Key exclusion criteria	Added as of 09/08/2007: Specific contraindications to surgery.
Date of first enrolment	01/06/2000
Date of final enrolment	30/09/2006

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Health Services Research Unit

Aberdeen
AB9 2ZD
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	cost-effectiveness results	01/09/2008		Yes	No
Results article	intial results	15/12/2008		Yes	No
Results article	results	14/07/2009		Yes	No
Results article	results	22/03/2010		Yes	No
Results article	results	18/04/2013		Yes	No
Results article	results	01/06/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes