Patient expectations for the outcome of anti-reflux surgery
Research type
Research Study
Full title
A prospective study to examine expectations for the outcome of anti-reflux surgery: the patients’ perspective
IRAS ID
206416
Contact name
S Dexter
Contact email
Sponsor organisation
The Leeds Teaching Hospital Trust
Duration of Study in the UK
1 years, 0 months, 15 days
Research summary
An abundance of literature exists which evaluates the outcome of anti-reflux surgery, many of which assess outcome in terms of changes in symptoms after surgery. A few studies have evaluated the patient's expected post-operative outcome of anti-reflux surgery. However, none have measured the patient's expected post-operative outcome in terms of quality of life (QOL). This would be a valuable measure of expected outcome since the majority of patients perceive treatment outcome in terms the impact on their QOL. This has been successfully achieved in other disease areas and a wealth of publications advocates the importance of addressing patient expectations in order to set realistic expectations before surgery. The proposed study will take place at the Leeds Teaching Hospitals Trust, and will involve recruiting 28 participants with gastro-oesophageal reflux disease (GORD), expecting to undergo primary anti-reflux surgery. Participants will be required to complete a previously validated, disease-specific, QOL questionnaire twice before anti-reflux surgery and once 6 months after anti-reflux surgery. The questionnaire is simple, consisting of 16-20 multiple choice questions, each taking approximately 5 minutes to complete. The main outcome of the study is to compare the participant's expected post-operative QOL score to their actual post-operative QOL score. A secondary study outcome will be to compare participant's expected post-operative QOL scores in different sub-groups of participants.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0202
Date of REC Opinion
15 Jun 2016
REC opinion
Favourable Opinion