Does the LINX procedure achieve similar reflux control and improve postoperative symptoms, specifically gas bloating and inability to belch, when compared to laparoscopic fundoplication?

Not Applicable

• Conditions: Gastro-oesophageal reflux disease; Digestive System

• Registration Number: ISRCTN13533177
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-03
• Last Update Posted: 18 June 2024
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 460

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptomatic GORD and health-related quality of life (HRQL) assessed using the GORD-HRQL questionnaire at 24 months following surgery