We are presenting a one year follow up of the initial experience with a transoral method for creating an anterior fundoplication (Dor-Thal) using the MediGus endoscopic stapling system (SRS)
The device is a stand alone single use flexible endoscope, which incorporates an ultrasonic range finder and a surgical stapler. The stapler fires a quintuplet of standard B shaped 4.8mm titanium staples. Using the device, a single operator can staple the fundus of the stomach to the esophagus, in 2-3 locations, 2-4 cm above the GE junction covering 90-210 degrees of the esophageal circumference. The result is an anterior partial fundoplication virtually identical to a Dor-Thal operation, with restoration of the gastroesophageal flap valve to normal .
Methods: In this prospective single arm study, 13 subjects with GERD were treated with the SRS device. Subjects were followed for up to 18 months. The main success criterion was reduction by at least 50% in GERD-HRQL scores. Secondary criteria included reduction of PPI usage, and reduction of acid exposure (% time pH < 4).
Results: There were 11 men and 2 women with a mean age of 43.3 years (23-64), all were on daily PPI, and the median duration of GERD symptoms was 2.5 years. The procedure was done under general anesthesia. PEEP was used to reduce the hiatal hernia, if present. Four subjects had two staplings, covering 90-100 degrees of the esophageal circumference. 9 subjects had 3 staplings (100-210 degrees). Median procedure times were 12 min (10-51) for the 1st stapling, 15 min (8-42) for the 2nd stapling, and 17 min (10-35) for the 3rd stapling. There was one procedure related adverse event – benign pneumoperitoneum – which resolved spontaneously within 48h.
12/13 (92%) reduced their GERD-HRQL scores by 50% or more. One improved from 29 to 15 The median GERD-HRQL scores dropped from 24 (10-38) to 5 (1-15). Median time pH
Session: Podium Presentation
Program Number: S081
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