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โ† Trials
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LINX vs Fundoplication

RecruitingPhase 3Ages 18 Years - anyAllUniversity of Oxford
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In plain words

What the trial is, and whether it could suit you

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 ne

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Laparoscopic or robotic LINX procedure
  • Laparoscopic or robotic fundoplication
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Where

5 sites
Guy's and St Thomas's NHS Foundation Trust, Guy's and St Thomas's Hospital
Oxford, United Kingdom
Imperial College Healthcare NHS Trust, St Mary's Hospital
Oxford, United Kingdom
Leeds Teaching Hospitals NHS Trust, St James's University Hospital
Oxford, United Kingdom
Oxford University Hospitals NHS Foundation Trust, Churchill Hospital
Oxford, United Kingdom
University Hospital Southampton NHS Foundation Trust
Oxford, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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