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29 August 2008
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| [ Print-friendly version ] |
| The place of minimal access surgery amongst people with Gastro-Oesophageal Reflux Disease (GORD) - a UK collaborative study |
| ISRCTN | ISRCTN15517081 |
| ClinicalTrials.gov identifier | |
| 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 the 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. Multicentre, pragmatic randomised trial (with parallel, non-randomised preference groups), Economic evaluation. Setting: Secondary care provided by gastro-enterologists and surgeons. Study hypothesis 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 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. Multicentre, 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). |
| Ethics approval | Added as of 09/08/2007: 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 | Digestive system diseases: Other digestive system disease |
| Participants - inclusion criteria |
Inclusion criteria amended as of 09/08/2007 (Please note that these amendments reflect errors in the information provided at time of registration):
Long-term proton pump inhibitor (PPI)-treated GORD patients suitable for surgical or medical secondary care management Inclusion criteria provided at time of registration: 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 | As of 09/08/2007: 810; Provided at time of registration: 357 |
| Interventions |
Please note that, as of 11 January 2008, the anticipated start and end dates of this trial have been updated from 1 October 1999 and 31 May 2011 to 1 June 2000 and 30 September 2006, respectively.
Interventions: 1. Laparoscopic surgery 2. Continued medical management Please note that an extended follow-up study of this trial started in May 2007 (HTA ref: 97/10/99), and that the anticipated end date of this trial provided at time of registration was 30/09/2004. |
| 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. Primary outcome measures provided at time of registration: 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) |
Provided 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 | |
| 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 |
| 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 |
| Sheila.Greener@doh.gsi.gov.uk | |
| Sponsor website: | http://www.dh.gov.uk/en/index.htm |
| Date applied | 25/04/2003 |
| Last edited | 15/04/2008 |
| Date ISRCTN assigned | 25/04/2003 |
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