A Pilot Study of an Endoscopic Surgical Stapler for the Treatment of GERD – Five Year Follow Up Results

Bapaye, Date, Pujari, Dorwat, and Roy-Shapira.
Presented at UEGWeek 2013.

Abstract

INTRODUCTION: From May - Oct 2007, an IRB approved pilot study of a new endoscopic stapling device (Medigus SRS™ device) for GERD treatment was conducted on 13 subjects. Inclusion - h/o PPI use > 2y for pH-metry proven GERD & no co-morbidity. The device is a flexible endoscopic surgical stapler with ultrasonic sight & range finder. It fires a staggered quintuplet of standard titanium B shaped 4.8mm surgical staples. It is guided into the stomach through the esophagus like a standard gastroscope. Cartridge is positioned in esophagus 2-3 cm above GE junction. Distal 21 cm is flexed in fundus, pushing it toward cartridge in esophagus. Ultrasonic sight is used to align cartridge in esophagus, measure intervening gap & allow compression to optimize firing range. Procedure repeated after replacing cartridge for 2nd or 3rd stapling. Result is an anterolateral true fundoplication functionally similar to Dor-Thal operation. A single operator did all procedures under general anesthesia.
AIMS&METHODS: Aim: To evaluate the 5-year follow up results of Medigus SRS™ fundoplication. As per original informed consent, subjects were contacted annually for 5 yrs, the final telephone interviews conducted in early October 2012. Following data were collected: Velanovich GERD-HRQL scores, PPI use, symptoms, satisfaction with the procedure & willingness to repeat procedure again. This data and the trends were compared to the 6-month & annual follow up data of these same subjects.
RESULTS: Each year, 11 / 13 subjects could be reached by phone (but not the same subjects each year). GERD-HRQL scores were reduced > 50% in all subjects but one. This subject had an initial score - 29, & had reported scores of 15 or 14 in different years. All subjects agreed to undergo the procedure again if required in future. Mean satisfaction score was 7.7 (6-10) on a scale 1-10 (1 – not satisfied, 10 – fully satisfied). None had dysphagia or gas bloat. In 1st 3 years, slight increase in PPI reuse was seen. 3 resumed daily PPI’s (compared to 2 at 2y follow up), 3 need reduced dose PPI (<50%), 1 takes PPI only after large meal & 4 are off PPI. No deterioration of results was seen after 3rd year.
CONCLUSION: At 5 years, the SRS procedure remained effective to improve QOL in moderate to severe GERD without causing dysphagia. PPI use was eliminated / reduced > 50% in 73% subjects. All subjects remain satisfied with the procedure & would do it all over again. There was no deterioration of results after 3rd year. This study suggests that at 5- years, results of SRS fundoplication are similar to laparoscopic fundoplication in terms of PPI use & QOL improvement.