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RefluxStop™

RefluxStop™

This innovative implant is exciting for both clinicians and patients as it restores the normal healthy anatomy at the base of your oesophagus; the procedure is completed within a day, using keyhole surgery. Early published results are excellent – showing normalisation of acid levels in the vast majority of patients, resulting in significantly improved quality of life survey scores.

RefluxStop™ also seems to negate some side effects associated with fundoplication and LINX™. Gas bloat, excessive wind and dysphagia (difficulty swallowing) are common after fundoplication while dysphagia can also occur following LINX™ (although is less common). Such potential benefits make RefluxStop™ an exciting possibility for a wider group of patients.

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How does it work?

RefluxStop™ treats acid reflux without affecting your oesophagus, potentially transforming the way acid reflux is treated. It’s a non-active implant that is placed on the upper part of your stomach using keyhole surgery. It was CE mark approved in August 2018 on the strength of a multi-centre clinical investigation that demonstrated its safety and effectiveness.

What are the results?

As it’s a new procedure, it’s important to emphasise the evidence base is currently small. Nevertheless, an important study into 50 patients was published in 2020* with these impressive outcomes:

  • No reported serious adverse events related to the device
  • 86% of patients had an improved quality of life (GERD HRQL questionnaire) 
  • 98% of those studied showed normal reflux levels after one year  
  • No dysphagia (difficulty swallowing)
  • A very significant improvement in gas bloat symptoms 
  • All of the patients were using PPI medication at baseline, but one year later only one patient was still using them

*Bjelovic et al, BMC Surgery 2020

What are the side effects and complications?

Current published data shows no serious side effects, either generally or specifically related to the device. However, we must bear in mind that the data is still limited due to the relative newness of the procedure.

As with any surgery, reflux surgery presents risks. Patients who proceed to having RefluxStop™ implantation are made fully aware of the following risks:

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

All such risks will be explained to you by your surgeon as well as those associated with keyhole surgery in general. They’re also specified in the consent form, which you’ll be asked to read before signing.

Does the effect last?

Initial results for the RefluxStop™ are excellent but still limited. It will take several years for us to develop a sound understanding of the long-term efficacy of the implant and to know other important factors such as re-operation rates. However, the data gathered so far is very encouraging.