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
Secondary identifying numbers HTA 97/10/03
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

Study website

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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymREFLUX
Study objectivesStudy 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) studiedGastro-oesophageal reflux disease
InterventionLaparoscopic surgery vs continued medical management
Intervention typeOther
Primary outcome measurePrimary 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 measuresAdded as of 09/08/2007:
The following are assessed through annual questionnaires:
1. Patient costs
2. Treatment changes
3. Side effects and complications
Overall study start date01/06/2000
Completion date30/09/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants810
Key inclusion criteriaInclusion 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 criteriaAdded as of 09/08/2007:
Specific contraindications to surgery.
Date of first enrolment01/06/2000
Date of final enrolment30/09/2006

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Health Services Research Unit
Aberdeen
AB9 2ZD
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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