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| ID | Type | Description | Link |
|---|---|---|---|
| NIHR152268 | Other Grant/Funding Number | National Institute for Health and Care Research | |
| ISRCTN 13533177 | Registry Identifier | ISRCTN: the UK's Clinical Study Registry |
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| Name | Class |
|---|---|
| King's College London | OTHER |
| Imperial College London | OTHER |
| Oxford University Hospitals NHS Trust | OTHER |
| Guy's and St Thomas' NHS Foundation Trust |
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Reflux disease can severely impact upon quality-of-life and lead to complications, including ulceration of the oesophagus. It is often controlled with self-help measures and medication. However, sometimes surgery is recommended. The current standard surgical treatment is called a fundoplication. This operation is carried out through keyhole (laparoscopic) surgery, and tightens the lower oesophagus to prevent reflux. Fundoplication is very safe and improves the quality-of-life of most patients. However, many patients have gas bloating, difficulty swallowing and recurrence of their reflux symptoms. As an alternative, some surgeons use a device called LINX, using a keyhole procedure. LINX is a magnetic device that wraps around the lower oesophagus to prevent reflux. Studies suggest that LINX may cause fewer complications, with a similar improvement in quality-of-life. However, there is a need for better evidence to compare LINX with fundoplication in the surgical treatment of reflux disease. GOLF is a multi-centre study designed which to determine if LINX achieves similar reflux control and improves symptoms compared to fundoplication. GOLF measures: (1) quality of life,(2) surgical complications, including need for additional treatment, (3) financial cost-effectiveness and (4) objectively measure the presence of acid that has refluxed into the lower oesophagus. GOLF aims randomise 460 patients to receive fundoplication or the LINX device. It will be conducted across at least 16 UK and 7 European specialist surgical centres. All participants will be followed up at 6 weeks, 6, 12 and 24 months to assess which treatment offers the best results after surgery. A quality assurance programme within participating centres will ensure that procedures are completed to a high-quality standard. Study results will incorporate a patient and public involvement programme, which will inform national and international guidelines for the surgical treatment of reflux disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic or robotic fundoplication | Active Comparator | Participants randomised to laparoscopic or robotic fundoplication will receive surgical treatment for managing GORD including a total or partial fundic wrap behind or in front of the distal oesophagus and gastro-oesophageal junction. |
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| Laparoscopic or robotic LINX procedure | Experimental | Participants randomised to laparoscopic or robotic magnetic sphincter augmentation (LINX procedure) will receive surgical treatment under general anaesthesia, with placement of the LINX device around the distal oesophagus. The LINX device comprises titanium beads with magnets in the centre. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic or robotic LINX procedure | Procedure | Participants randomised to laparoscopic or robotic magnetic sphincter augmentation (LINX procedure) will receive surgical treatment under general anaesthesia, with placement of the LINX device around the distal oesophagus. The LINX device comprises titanium beads with magnets in the centre. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic GORD and health-related quality of life (HRQL) assessed using the GORD-HRQL questionnaire | 24 months following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of gas bloating measured using participant-reported outcomes/GORD-HRQL and Foregut Symptom Questionnaire | 24 months postoperatively | |
| Prevalence of inability to belch measured using participant-reported outcomes/GORD-HRQL and Foregut Symptom Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheraz Markar, PhD, FRCS, MSc, MA | Contact | +44 07584039433 | golf@nds.ox.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's and St Thomas's NHS Foundation Trust, Guy's and St Thomas's Hospital | Recruiting | Oxford | Oxfordshire | OX3 7LD | United Kingdom |
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| Label | URL |
|---|---|
| Study website | View source |
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The data-sharing plans for the current study are unknown and will be made available at a later date.
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| OTHER |
| University of Bristol | OTHER |
| University of Southampton | OTHER |
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| Laparoscopic or robotic fundoplication | Procedure | Participants randomised to laparoscopic or robotic fundoplication will receive surgical treatment for managing GORD including a total or partial fundic wrap behind or in front of the distal oesophagus and gastro-oesophageal junction. |
|
| 24 months postoperatively |
| Prevalence of symptomatic GORD, inability to belch and gas bloating measured using participant-reported outcomes/GORD-HRQL and Foregut Symptom Questionnaire | 6 weeks, 6 and 12 months after surgery |
| Severity of dysphagia and regurgitation measured using participant-reported outcomes/GORD-HRQL questionnaire | 6 weeks, 6, 12 and 24 months postoperatively |
| Global HRQL measured using participant-reported outcomes/EQ-5D-5L questionnaire | 6 weeks, 6, 12 and 24 months postoperatively |
| Utilisation of anti-GORD medications measured using participant-reported outcomes/questionnaire | 6 weeks, 6, 12 and 24 months postoperatively |
| 24-hour pH measurement measured using participant's medical records/24-hour pH measurement or BRAVO test | 12 months postoperatively |
| Postoperative complication rates, including reoperation and endoscopic reintervention, measured using participant's medical records/postoperative outcomes | 30-day, 90-day, 12 and 24-month |
| Cost-effectiveness of both treatments as measured by incremental cost per quality-adjusted life year (QALY) | 6 weeks, 6, 12 and 24 months postoperatively |
| Imperial College Healthcare NHS Trust, St Mary's Hospital | Recruiting | Oxford | Oxfordshire | OX3 7LD | United Kingdom |
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| Leeds Teaching Hospitals NHS Trust, St James's University Hospital | Recruiting | Oxford | Oxfordshire | OX3 7LD | United Kingdom |
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| Oxford University Hospitals NHS Foundation Trust, Churchill Hospital | Recruiting | Oxford | Oxfordshire | OX3 7LD | United Kingdom |
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| University Hospital Southampton NHS Foundation Trust | Recruiting | Oxford | Oxfordshire | OX3 7LD | United Kingdom |
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| D004066 | Digestive System Diseases |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |