A retrospective, observational study investigating the long-term clinical outcomes of post-laparoscopic sleeve gastrectomy (LSG) patients with Gastroesophageal Reflux Disease (GERD) who received the LINX™ Reflux Management System.
One of the reported consequences of laparoscopic sleeve gastrectomy is an increase in post-operative GERD symptoms and de novo GERD.1-3 If antireflux medications are not effective in treating GERD symptoms, alternative treatments are limited for this population. The traditional surgical approach of performing a fundoplication is no longer an option due to the change in the patient’s anatomy post-LSG. A conversion to Roux-en-Y Gastric bypass (RYGB) may be proposed but not all patients may be interested in undergoing this procedure. A recently conducted clinical study demonstrated that LINX is a potential and viable surgical alternative to fundoplication, but the initial post-market IDE trial was small (n=30) and short in duration (12-months of follow-up). Additional research is warranted.
ETHICON, Inc. is interested in receiving proposals for investigating long-term clinical outcomes (>1-5 years) in a larger group of post-laparoscopic sleeve gastrectomy patients with GERD who have been implanted with the LINX device.
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