Evaluation of a Viscerotomy Formation and Closure Device for Natural Orifice Surgery in a Survival Model

Introduction: The most challenging of the many hurdles surgeons must overcome to safely perform NOTES is viscerotomy closure. The perfect device must be easy to deploy, can be used on any viscera, and will create a rapid, reliable and durable closure. To date, new devices created for this purpose have fallen well short of these goals. A novel device was used in a survival canine study to confirm adequacy of gastric closure and rapidity of deployment.
Materials and Methods: Five mongrel dogs undergoing a transgastric intraabdominal surgery were used for this study. A Surgassist™ (PMI, Langhorne, PA) powered circular stapler (EEA) modified with an auger tip and pre-mounted suture was used to create and then close the gastrotomy through which the procedure was performed. Total time for deployment and closure was calculated. Each animal was survived for 14 days, euthanized and a necropsy carried out. Cultures of a random site within the peritoneal cavity and at the site of the gastrotomy were obtained. In addition a visual inspection of the peritoneal cavity was performed and the site of closure was sectioned for histologic evaluation.
Results: Deployment and closure of the device was successful in all subjects. All animals survived for the two week study period without signs of sepsis. The mean time for deployment and closure was 4.8 minutes. At necropsy the closures were found to be intact and re-epithelialized. No intraabdominal abscesses were found and all cultures had no growth. Adhesions at the gastrotomy site were found in four out of five animals.
Conclusions: The prototype transvisceral purse-string device consistently produced a safe and reliable closure. With minimal practice it can be deployed and cinched closed rapidly. This study provides further evidence that this new device may be a promising option for use in NOTES.

Session: Podium Presentation

Program Number: S076

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