Comparing surgical procedures for gastro-oesophageal reflux disease

The aim of this project is to compare two types of surgical procedure performed by surgeons to improve symptoms of gastro-oesophageal reflux disease (GORD). This study will be led from Oxford. We are providing expertise in quality assurance (described here) and in recruitment (not included here). Our role is to obtain and analyse surgical videos of participants undergoing fundoplication (standard surgery) or LINX procedure (new method) to see how the surgery is performed.

GORD is a condition in which acid from the stomach passes back (reflux) into the gullet (oesophagus). Most people find GORD to be only an occasional nuisance, but it can severely impact quality-of-life for some. In some instances, surgery is recommended.

Currently the best surgical treatment for GORD is called a laparoscopic fundoplication. A laparoscopy is a surgical procedure during which a surgeon accesses the inside of the abdomen and pelvis without making large incisions in the skin. Fundoplication involves wrapping the top part of your stomach around your lower oesophagus (the tube that carries food from your mouth to your stomach). A significant number of patients suffer from gas bloating, difficulty swallowing and a recurrence of their GORD symptoms after this procedure.

As an alternative to fundoplication, some surgeons have started using a novel device called LINX. A LINX device is a small magnetic device fitted around the lower oesophagus by a surgeon during laparoscopic surgery. This is done while the patient is under a general anaesthetic.

The main study will establish whether the LINX procedure achieves similar reflux control and improves post-operative symptoms – specifically gas bloating and inability to belch –compared to fundoplication. The quality assurance work we will undertake will examine how standards of surgery are undertaken in the trial and therefore inform what is needed in practice thereafter. We hope that this research will help us determine whether the LINX procedure can safely overtake fundoplication as the primary means of surgical treatment for GORD and how it is best performed.