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The place of minimal access surgery amongst people with gastro-oesophageal reflux disease (GORD) - a UK collaborative study
ISRCTN ISRCTN15517081
DOI 10.1186/ISRCTN15517081
ClinicalTrials.gov identifier
EudraCT number
Public title The place of minimal access surgery amongst people with gastro-oesophageal reflux disease (GORD) - a UK collaborative study
Scientific title
Acronym REFLUX
Serial number at source HTA 97/10/03
Study hypothesis 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).
Lay summary Not provided at time of registration
Ethics approval Approved by Medical Research Ethics Committee for Scotland and Local Research Ethics Committees.
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Gastro-oesophageal reflux disease
Participants - 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
Participants - exclusion criteria Added as of 09/08/2007:
Specific contraindications to surgery.
Anticipated start date 01/06/2000
Anticipated end date 30/09/2006
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 810
Interventions Laparoscopic surgery vs continued medical management
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.
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
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website http://www.abdn.ac.uk/hsru/hta/reflux.shtml
Publications 1. 2008 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/18796263
2. 2008 intial results in: http://www.ncbi.nlm.nih.gov/pubmed/19074946
3. 2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19654097
4. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20307273
5. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23599318
6. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23742987
Contact name Prof  Adrian  Grant
  Address Health Services Research Unit
University of Aberdeen
Polwarth Building
Foresterhill
  City/town Aberdeen
  Zip/Postcode AB9 2ZD
  Country United Kingdom
  Tel +44 (0)1224 553908
  Fax +44 (0)1224 663087
  Email a.grant@adn.ac.uk
Sponsor Department of Health (UK)
  Address Quarry House
Quarry Hill
  City/town Leeds
  Zip/Postcode LS2 7UE
  Country United Kingdom
  Tel +44 (0)1132 545 843
  Email Sheila.Greener@doh.gsi.gov.uk
  Sponsor website: http://www.dh.gov.uk/en/index.htm
Date applied 25/04/2003
Last edited 24/02/2014
Date ISRCTN assigned 25/04/2003
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