Condition category
Digestive System
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
24/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.abdn.ac.uk/hsru/hta/reflux.shtml

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 measures

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

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

http://www.dh.gov.uk/en/index.htm

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Additional files

Editorial Notes