RefluxStop™

The early published results are excellent. They show normalisation of acid levels in the vast majority of patients and, as a consequence, quality of life survey scores show significant improvement. You can read more on outcomes further down this page.

Another attractive feature of RefluxStop is that it appears to negate two of the issues that cause patients concern following fundoplication and LINX®️. Specifically gas bloat, excessive wind and dysphagia (difficulty swallowing) are common problems following fundoplication. Similarly dysphagia can also occur following LINX®️ although less commonly. These potential benefits open RefluxStop to a wider group of patients.

How does it work?

RefluxStop treats acid reflux without affecting the oesophagus, a novel method that could eventually change the way acid reflux is treated. The ingenious RefluxStop ™ device is a non-active implant that is placed on the upper part of the stomach through laparoscopic (keyhole) surgery. CE mark approval was granted in August 2018, on the strength of a multi-centre clinical investigation in which the safety and effectiveness of the device in patients was demonstrated.

What are the results?

It’s important to stress that the RefluxStop procedure is new so the evidence base is still small. That said, an important study into 50 patients was published in 2020*. The impressive headlines are as follows:

• No reported serious adverse events related to the RefluxStop device
• Quality of life, measured by GERD HRQL questionnaire, improved from baseline in 86% of patients
• 98% of study subjects had normal reflux levels after one year
• No dysphagia (difficulty swallowing) - sometimes a concern about other procedures
• Gas bloat symptoms were very significantly improved
• Perhaps most importantly, all 50 subjects were using PPI medication at baseline, one year later only one patient was using them

*Bjelovic et al, BMC Surgery 2020

What are the side effects and complications?

The current published data shows no serious side effects, either generally or specifically related to the device. It is important to remember however that the data is still thin at the moment as this is a new procedure.

All reflux surgery carries some risk and those patients who proceed to RefluxStop ™ surgery will do so in the knowledge of the following risks:

• Haemorrhage (bleeding)
• Visceral injury
• Vagal injury
• Recurring hiatal hernia

These risks and those that apply more generally to laparoscopic (keyhole) surgery would be explained by your surgeon ahead of your surgery and more specifically in the consent form you will be asked to sign.

Does the effect last?

Initial results for the RefluxStop are excellent but it’s still early days. As with all new devices, it will take several years to develop a deep understanding of the long-term efficacy of a procedure and the important factors such as re-operation rates. For now however the safety and efficacy data is good.

What about recovery following the surgery?

RefluxStop is a day case procedure. As such there will be a short recovery period. Patients can expect to be up and about within hours of their surgery and then slowly resuming normal day to day activities over a couple of weeks. It’s especially important to take things easily in the first week post op and not to overdo it during the initial healing process.

Importantly, the effect of RefluxStop is immediate so patients can expect to resume a normal diet within a few hours of surgery. For long suffering reflux patients this can be one of the major benefits of RefluxStop surgery.

Why people choose RefluxUK for their RefluxStop surgery?

RefluxUK was the first clinic in the UK to offer the RefluxStop procedure and have performed more RefluxStop procedures than any other clinic in the UK. Our team has expertise across all of the treatment options and we bring that expertise together through our reflux multi-disciplinary team. This team includes specialist reflux clinicians with backgrounds in Upper GI (gastroenterology and surgery), ENT, physiology and nursing. Together they ensure that all surgical patients benefit from in-depth and impartial scrutiny to deliver the best possible outcomes.

Page reviewed by: Mr Nick Boyle BM MS FRCS 01/09/24