Developers of RefluxStop, a device designed to treat gastro-esophageal reflux disease (GERD) without putting pressure on the oesophagus, have hailed promising results following long-term studies.
It is also claimed that the RefluxStop procedure treats acid reflux more effectively and with fewer side effects compared to Nissen fundoplication – a procedure traditionally seen as the ‘gold standard’ for patients who don’t fully respond to medications.
RefluxStop is a relatively new device that works by repositioning the lower oesophageal sphincter to prevent acid reflux. Nissen fundoplication, on the other hand, is a long-established surgical method where part of the stomach is wrapped around the lower oesophagus to help control reflux.
Findings
Recent data presented at the 27th Annual Scientific Meeting of the Association of Upper Gastrointestinal Surgery (AUGIS) in Manchester shared results from a study conducted in Germany, where 158 GERD patients received the RefluxStop device.
The findings showed that two years after the procedure, over 90 per cent of patients reported a significant improvement in their quality of life. Additionally, 96.4 per cent of patients were able to stop taking proton pump inhibitors (PPIs), a medication commonly prescribed to control GERD symptoms.
These findings are particularly noteworthy because many of the patients had complex cases. For example, 22 per cent had large hiatal hernias, and 10 per cent showed early signs of Barrett’s oesophagus, a condition that can increase the risk of oesophageal cancer. Despite these challenges, the RefluxStop procedure resulted in considerable symptom relief.
Dr Moustafa Elshafei, one of the study leads, commented: “We are delighted by the outcomes of this new procedure and the significant interest in RefluxStop at AUGIS. It is great to see my UK peers so open and willing to embrace this cutting-edge technology and help drive innovation in the surgical treatment of GERD.”
Comparison with traditional surgery
Nissen fundoplication, the traditional surgical method for treating severe GERD, involves wrapping part of the stomach around the lower oesophagus to prevent acid reflux. However, the Nissen procedure can cause significant side effects, such as difficulty swallowing (dysphagia), gas bloating and the inability to belch or vomit.
A recent review of studies on Nissen fundoplication highlighted the extent of these side effects. Gas bloating occurs in over half of the patients (52.7 per cent), difficulty swallowing affects 28.9 per cent and 39.8 per cent of patients are unable to belch or vomit after the surgery.
By comparison, the RefluxStop study reported much lower rates of complications: only nine per cent of patients experienced gas bloating, and just 2.3 per cent had swallowing difficulties, making it a potentially more comfortable alternative for post-operative recovery.
Commenting on these outcomes, Dr Thorsten Lehmann, another study lead, also commented: “This paper shows that RefluxStop could allow me to offer more patients with large hiatal hernia the durable benefits of a surgical treatment for GERD. I am thrilled to see such promising results in close to 200 patients I have treated over the past three years and what it could mean for many more patients who were not eligible for the traditional anti-reflux surgeries in the past.”
Future of treatment
With GERD affecting millions globally, including 9.5 million people in the UK alone, treatments like RefluxStop are gaining attention. While traditional methods such as Nissen fundoplication are well-established, their side effects have led to growing interest in alternatives that may offer patients symptom relief with fewer complications.
RefluxStop’s approach, which aims to restore the natural position of the oesophageal sphincter without encircling the oesophagus, could represent a significant step forward.
Dr. Peter Forsell, CEO of Implantica, reflected on the broader implications: “As the results indicate, the non-encircling nature and unique mechanism of action of the RefluxStop procedure both treat acid reflux better and with much fewer side effects.”
Conclusion
While early data from studies of RefluxStop are promising, it’s important to remember that more research is needed to fully assess its long-term effectiveness and safety. However, for patients struggling with severe GERD, RefluxStop could present a viable option with fewer side effects compared to traditional surgical methods.
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