Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Adrian Grant
ORCID ID
Contact details
Health Services Research Unit
University of Aberdeen
Polwarth Building
Foresterhill
Aberdeen
AB9 2ZD
United Kingdom
+44 (0)1224 553908
a.grant@adn.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 97/10/03
Study information
Scientific title
Acronym
REFLUX
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).
Ethics approval
Approved by Medical Research Ethics Committee for Scotland and Local Research Ethics Committees.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Gastro-oesophageal reflux disease
Intervention
Laparoscopic surgery vs continued medical management
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
Added as of 09/08/2007:
The following are assessed through annual questionnaires:
1. Patient costs
2. Treatment changes
3. Side effects and complications
Overall trial start date
01/06/2000
Overall trial end date
30/09/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
810
Participant exclusion criteria
Added as of 09/08/2007:
Specific contraindications to surgery.
Recruitment start date
01/06/2000
Recruitment end date
30/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Health Services Research Unit
Aberdeen
AB9 2ZD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (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
Basic results (scientific)
Publication list
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
Publication citations
-
Intial results
Grant AM, Wileman SM, Ramsay CR, Mowat NA, Krukowski ZH, Heading RC, Thursz MR, Campbell MK, , Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease: UK collaborative randomised trial., BMJ, 2008, 337, a2664.
-
Results
Epstein D, Bojke L, Sculpher MJ, , Laparoscopic fundoplication compared with medical management for gastro-oesophageal reflux disease: cost effectiveness study., BMJ, 2009, 339, b2576.
-
Results
McCann SK, Campbell MK, Entwistle VA, Reasons for participating in randomised controlled trials: conditional altruism and considerations for self., Trials, 2010, 11, 31, doi: 10.1186/1745-6215-11-31.
-
Results
Grant AM, Cotton SC, Boachie C, Ramsay CR, Krukowski ZH, Heading RC, Campbell MK, , Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX)., BMJ, 2013, 346, f1908.
-
Results
Grant AM, Boachie C, Cotton SC, Faria R, Bojke L, Epstein DM, Ramsay CR, Corbacho B, Sculpher M, Krukowski ZH, Heading RC, Campbell MK, , Clinical and economic evaluation of laparoscopic surgery compared with medical management for gastro-oesophageal reflux disease: 5-year follow-up of multicentre randomised trial (the REFLUX trial)., Health Technol Assess, 2013, 17, 22, 1-167, doi: 10.3310/hta17220.
-
Grant A, Wileman S, Ramsay C, Bojke L, Epstein D, Sculpher M, Macran S, Kilonzo M, Vale L, Francis J, Mowat A, Krukowski Z, Heading R, Thursz M, Russell I, Campbell M, , The effectiveness and cost-effectiveness of minimal access surgery amongst people with gastro-oesophageal reflux disease - a UK collaborative study. The REFLUX trial., Health Technol Assess, 2008, 12, 31, 1-181, iii-iv.