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

Completed

Conditions: Gastro-oesophageal reflux disease
Digestive System

Registration Number: ISRCTN15517081

Lead Sponsor: Department of Health (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 810

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measures amended as of 09/08/2007: <br>Cost and outcome measurement (assessed through annual questionnaires): <br>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.<br>2. Treatment preferences and attitudes to surgery and medical management. <br>3. Indices of differential cost effectiveness with economic modelling. <br><br>Previous primary outcome measures: <br>Cost and outcome measurement: <br>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. <br>2. Prevalence PPI for GORD (>12 months); treatment preferences and attitude to surgery. <br>3. Indices of differential cost effectiveness and economic models of NHS uptake of minimal access surgery.

Secondary Outcome Measures

Name	Time	Method
Added as of 09/08/2007: <br>The following are assessed through annual questionnaires:<br>1. Patient costs<br>2. Treatment changes<br>3. Side effects and complications