Jonathan R Thompson, MD1, Brad Watkins, MD2, Angelo Iossa, MD2, Kevin M Tymitz, MD3, Tayyab S Diwan, MD2. 1University of Cincinnati Research Institute, 2University of Cincinnati, 3TriHealth Weight Management Center, Good Samaritan TriHealth Hospital
Objective of the technology or device:
Sleeve gastrectomy pouches are usually created by stapling next to an orogastric tube with divergent techniques between surgeons, resulting in variant sleeve gastrectomy pouch characteristics. The Standard Clamp allows the surgeon to plan the full sleeve gastrectomy staple line prior to stapling and holds both sides of the stomach in place during stapling.
Description of the technology and method of its use or application:
The Standard Clamp is a reusable laparoscopic clamp. The clamp has the ability to clamp along the full length of a sleeve gastrectomy staple line in a non-parallel fashion with a floating jaw design.
The Standard Clamp is placed from a right sided trocar. The clamp is positioned on both sides of the stomach and closed such that the stomach will slide between the jaws. The three key landmarks of sleeve gastrectomy are then aligned – 4-6 cm from the pylorus, 2-3 cm from the incisura angularis, and 1cm from the gastroesophageal junction – positioning the stomach relative to the clamp. The clamp is then tightened to hold the stomach in place. Stapling is performed to the anatomic left of the clamp with an assistant providing counter-traction against the clamp.
Preliminary results if available:
We have performed a comparative tissue damage test. We placed clamps onto a live porcine stomach for 21.5 minutes (a 2X safety margin) and staplers onto the stomach for 15 seconds then removed the stomach and had an independent pathologist assess for tissue damage. The clamps were ranked from most damaging to least damaging: The Debakey grasper (complete damage to mucosa) followed by Crocodile grasper (Mucosal linear damage), then by Ethicon Echelon Black (superficial damage to serosal side of muscularis layer), Kocher Clamp (Linear tear in mucosa), then followed by Coviden Tristaple Black (Linear tear in mucosal layer) then followed by Standard Clamp at gastric antrum (focal linear tear). The other three clamps had no detectable damage: the Standard Clamp at gastric body, Standard Clamp at gastric fundus and Doyen.
We have performed laparoscopic sleeve gastrectomy procedures on two human cadavers using the clamp. In both cases, we were able to create a curved sleeve with ideal characteristics (4-6cm from the pylorus, 2-3cm from the incisura angularis, 1cm from the gastroesophageal junction). The visual appearance is a curved sleeve from a straight staple line.
Conclusions / future directions:
The Standard Clamp gives an alternative to orogastric calibration tubes in creating the sleeve gastrectomy pouch. It helps surgeons position the stomach and hold it in place during stapling such that they define the anatomy of the stomach that will remain in the patient. This will enable surgeons to better control sleeve gastrectomy anatomy. We are planning a single site randomized controlled trial and a multisite registry to evaluate the clamp in use. We are also developing a bougie to complement the clamp to allow for more precise control of the resultant sleeve gastrectomy anatomy.
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