Double-blind Randomised Controlled Trial for Treatment of Gastro-Oesophageal Reflux Disease; LINX Management System vs. Fundoplication (GOLF)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 460
- 试验地点
- 10
- 主要终点
- Symptomatic GORD and health-related quality of life (HRQL) assessed using the GORD-HRQL questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and above
- •Willing and able to give informed consent
- •Patients with GORD insufficiently controlled by medical therapy or intolerance to medical therapy being considered for anti-reflux surgery
- •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
- •No hiatal hernia or hiatal hernia <5 cm in length
- •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.
排除标准
- •Unsuitable for surgical intervention due to medical conditions precluding general anaesthesia
- •Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials
- •Previous anti-reflux or gastric surgery
- •Previous or planned neurosurgical intervention
- •Oesophageal manometry showing complete absence of lower oesophageal contractility
结局指标
主要结局
Symptomatic GORD and health-related quality of life (HRQL) assessed using the GORD-HRQL questionnaire
时间窗: 24 months following surgery
次要结局
- Prevalence of inability to belch measured using participant-reported outcomes/GORD-HRQL and Foregut Symptom Questionnaire(24 months postoperatively)
- 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)
- Prevalence of gas bloating measured using participant-reported outcomes/GORD-HRQL and Foregut Symptom Questionnaire(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)
- 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)
- Utilisation of anti-GORD medications measured using participant-reported outcomes/questionnaire(6 weeks, 6, 12 and 24 months postoperatively)