BACKGROUND: Secure closure of the colonic access site is one of the most important issues for the development of natural orifice transluminal endoscopic surgery. OBJECTIVE: To evaluate the feasibility, reproducibility, and efficacy of a new over-the-scope clip. DESIGN: Descriptive study, in vivo porcine colon. INTERVENTION: In 10 female Yorkshire pigs weighing 30 to 35 kg, a 10-mm colotomy was performed by using a needle-knife and advancing the endoscope to the peritoneal cavity. Colonic closure was performed by using the Padlock-G clip (Aponos Medical, Kingston, NH) delivered with the Lock-It system (Aponos). MAIN OUTCOME MEASUREMENTS: Animals were monitored daily for signs of peritonitis and sepsis over a period of 14 days. During necropsy, the peritoneal cavity was examined, and the colon segment containing the incision was excised for pathological study. RESULTS: Closure was achieved in all cases. Nine of 10 pigs survived 14 days without complications, but 1 pig was killed immediately after the procedure because of severe bleeding during the colonic incision. The median closure time was 8 minutes (range 1-30 minutes). At necropsy, adhesions were observed in 5 cases. The incision was hardly visible at the serosa side in 3 cases and was not identified in 6 cases. In 6 cases, the clip was still slightly attached to the mucosa, and it was not found in 3 cases. The pathological study revealed a complete remodeling of the colonic wall in all cases. LIMITATIONS: Animal model, noncomparative study. CONCLUSION: The Padlock-G clip procedure is feasible, reproducible, effective, and easy to perform, and it provides a reliable colonic closure.
BACKGROUND: Secure closure of the colonic access site is one of the most important issues for the development of natural orifice transluminal endoscopic surgery. OBJECTIVE: To evaluate the feasibility, reproducibility, and efficacy of a new over-the-scope clip. DESIGN: Descriptive study, in vivo porcine colon. INTERVENTION: In 10 female Yorkshire pigs weighing 30 to 35 kg, a 10-mm colotomy was performed by using a needle-knife and advancing the endoscope to the peritoneal cavity. Colonic closure was performed by using the Padlock-G clip (Aponos Medical, Kingston, NH) delivered with the Lock-It system (Aponos). MAIN OUTCOME MEASUREMENTS: Animals were monitored daily for signs of peritonitis and sepsis over a period of 14 days. During necropsy, the peritoneal cavity was examined, and the colon segment containing the incision was excised for pathological study. RESULTS: Closure was achieved in all cases. Nine of 10 pigs survived 14 days without complications, but 1 pig was killed immediately after the procedure because of severe bleeding during the colonic incision. The median closure time was 8 minutes (range 1-30 minutes). At necropsy, adhesions were observed in 5 cases. The incision was hardly visible at the serosa side in 3 cases and was not identified in 6 cases. In 6 cases, the clip was still slightly attached to the mucosa, and it was not found in 3 cases. The pathological study revealed a complete remodeling of the colonic wall in all cases. LIMITATIONS: Animal model, noncomparative study. CONCLUSION: The Padlock-G clip procedure is feasible, reproducible, effective, and easy to perform, and it provides a reliable colonic closure.