Gastro-oesophageal reflux disease Digestive System
Conditions
Interventions
The GOLF study is a multi-centre, pragmatic, two-arm, double-blind, Phase III, randomized controlled trial (RCT). An embedded QuinteT Recruitment Intervention will be used to understand, monitor and a
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 years and above 2. Willing and able to give informed consent 3. Patients with GORD insufficiently controlled by medical therapy or intolerance to medical therapy being considered for anti-reflux surgery 4. Symptomatic and objectively defined GORD; endoscopy with appearances or biopsies consistent with reflux oesophagitis, or 24-hour pH study or BRAVO test of the oesophagus consistent with GORD 5. No hiatal hernia or hiatal hernia 30 mmHg or DCI >450 mmHg-s-cm in 70% of swallows.
Exclusion criteria
Exclusion criteria: 1. Unsuitable for surgical intervention due to medical conditions precluding general anaesthesia 2. Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials 3. Previous anti-reflux or gastric surgery 4. Previous or planned neurosurgical intervention 5. Oesophageal manometry showing complete absence of lower oesophageal contractility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptomatic GORD and health-related quality of life (HRQL) assessed using the GORD-HRQL questionnaire at 24 months following surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Prevalence of gas bloating measured using participant-reported outcomes/GORD-HRQL and Foregut Symptom Questionnaire at 24 months postoperatively 2. Prevalence of inability to belch measured using participant-reported outcomes/GORD-HRQL and Foregut Symptom Questionnaire at 24 months postoperatively 3. Prevalence of symptomatic GORD, inability to belch and gas bloating measured using participant-reported outcomes/GORD-HRQL and Foregut Symptom Questionnaire at 6 weeks, 6 and 12 months after surgery 4. Severity of dysphagia and regurgitation measured using participant-reported outcomes/GORD-HRQL questionnaire at 6 weeks, 6, 12 and 24 months postoperatively 5. Global HRQL measured using participant-reported outcomes/EQ-5D-5L questionnaire at 6 weeks, 6, 12 and 24 months postoperatively 6. Utilisation of anti-GORD medications measured using participant-reported outcomes/questionnaire at 6 weeks, 6, 12 and 24 months postoperatively 7. 24-hour pH measurement measured using participant’s medical records/24-hour pH measurement or BRAVO test at 12 months postoperatively 8. 30-day, 90-day, 12 and 24-month postoperative complication rates, including reoperation and endoscopic reintervention, measured using participant’s medical records/postoperative outcomes 9. Cost-effectiveness of both treatments as measured by incremental cost per quality-adjusted life year (QALY) at 6 weeks, 6, 12 and 24 months postoperatively | — |
Countries
England, United Kingdom
Outcome results
None listed