LINX vs Fundoplication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-06

Study Completion Date

2029-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Gastro-oesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Laparoscopic or robotic fundoplication

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.

Group Type ACTIVE_COMPARATOR

Laparoscopic or robotic fundoplication

Intervention Type 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.

Laparoscopic or robotic LINX 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.

Group Type EXPERIMENTAL

Laparoscopic or robotic LINX procedure

Intervention Type 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.

Interventions

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Laparoscopic or robotic LINX 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.

Intervention Type PROCEDURE

Laparoscopic or robotic fundoplication

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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