The place of minimal access surgery amongst people with gastro-oesophageal reflux disease (GORD) - a UK collaborative study

Conditions

Gastro-oesophageal reflux disease Digestive System Gastro-oesophageal reflux disease

Grant AM, Boachie C, Cotton SC, Faria R, Bojke L, Epstein DM, Ramsay CR, Corbacho B, Sculpher M, Krukowski ZH, Heading RC, Campbell MK, REFLUX trial group.

2013-06-0149 citations

10.3310/hta17220

Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX).

Grant AM, Cotton SC, Boachie C, Ramsay CR, Krukowski ZH, Heading RC, Campbell MK, REFLUX Trial Group.

2013-04-1849 citations

10.1136/bmj.f1908

Reasons for participating in randomised controlled trials: conditional altruism and considerations for self.

McCann SK, Campbell MK, Entwistle VA.

2010-03-22216 citations

10.1186/1745-6215-11-31

Laparoscopic fundoplication compared with medical management for gastro-oesophageal reflux disease: cost effectiveness study.

Epstein D, Bojke L, Sculpher MJ, REFLUX trial group.

2009-07-1440 citations

10.1136/bmj.b2576

Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease: UK collaborative randomised trial.

Grant AM, Wileman SM, Ramsay CR, Mowat NA, Krukowski ZH, Heading RC, Thursz MR, Campbell MK, REFLUX Trial Group.

2008-12-1565 citations

10.1136/bmj.a2664

The effectiveness and cost-effectiveness of minimal access surgery amongst people with gastro-oesophageal reflux disease - a UK collaborative study. The REFLUX trial.

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, REFLUX Trial Group.

2008-09-0151 citations

10.3310/hta12310

Interventions

Laparoscopic surgery vs continued medical management

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Added as of 09/08/2007: Specific contraindications to surgery.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
Added as of 09/08/2007: The following are assessed through annual questionnaires: 1. Patient costs 2. Treatment changes 3. Side effects and complications	—

Countries

United Kingdom

Outcome results

None listed