Trial summary at a glance

Hypothesis

The laparoscopic LINX procedure will achieve reflux control equivalent to laparoscopic fundoplication, with fewer side effects, particularly gas bloating and inability to belch at 24 months after surgery.

Study population

460 patients receiving anti-reflux surgery for objectively confirmed GORD (Gastroesophageal Reflux Disease) that is insufficiently controlled with medical therapy or those intolerant of medical therapy.

Study aim

To determine whether the LINX procedure achieves similar reflux control and improves postoperative symptoms, specifically gas bloating and inability to belch, when compared to fundoplication at 24 months after surgery.

Primary outcome

Assessment of symptomatic GORD and HRQL using the GORD-HRQL questionnaire at 24 months following surgery.

Study design

A prospective, multi-centre, pragmatic, double-blind, phase III RCT design, randomising patients I:I between laparoscopic/robotic LINX procedure and laparoscopic/robotic fundoplication.

Secondary outcomes

Prevalence of gas bloating at 24 months postoperatively. Prevalence of inability to belch at 24 months postoperatively.