ISRCTN13533177Active, not recruitingUnknown
Double-blind randomised controlled trial for treatment of Gastro-Oesophageal reflux disease; LINX management system vs Fundoplication (GOLF)
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Active, not recruiting
- Sponsor
- niversity of Oxford
- Enrollment
- 460
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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 <5 cm in length
- •6. Adequate lower oesophageal motility as defined by preoperative oesophageal manometry study. Oesophageal manometry will show a mean contractile amplitude of >30 mmHg or DCI >450 mmHg-s-cm in 70% of swallows.
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
Investigators
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