Evaluation of a novel access and closure device for NOTES applications: a transcolonic survival study in the porcine model (with video)

Background: Natural orifice transluminal endoscopic surgery (NOTES) is a novel, potentially less invasive alternative to laparoscopic surgery. However, the problems of transluminal access and closure represent significant obstacles to its successful introduction in humans. Objective: Our purpose was to evaluate the feasibility and safety of a novel device designed for transluminal access and closure. Design: Experimental endoscopic study of transcolonic incision and closure with use of a prototype device in a survival porcine model. Subjects: Four adult female Yorkshire pigs were used in the study Interventions: While under general anesthesia, the animals were prepped with multiple tap water enemas followed by instillation of an antibiotic suspension and povidone-iodine lavage. At a distance of 15 to 20 cm from the anus, the prototype device deployed a circumscribing purse-string suture around the planned incision site and subsequently used a blade mechanism to create a 2.5-cm linear incision. The peritoneum was then accessed with a standard double-channel enodoscope. The transcolonic incision was then closed by cinching and securing the purse-string suture with a titanium knot by use of a separate hand-activated suture-locking device. All animals were allowed to eat immediately after recovering from general anesthesia. Main Outcome Measurements: The animals were monitored daily for signs of peritonitis and sepsis and were electively killed on day 14. The peritoneal cavity was examined for peritonitis, and the colonic incision site was examined for wound dehiscence, pericolic abscess formation, and gross adhesions. Tissue samples from both incisional and random peritoneal sites were obtained for histologic examination. Results: Transcolonic incision and closure were successful in all 4 animals. The device performed in a rapid and reproducible fashion. All animals recovered without septic complications. At necropsy there was no evidence of peritonitis, abscesses, or wound dehiscence. Salpingocolonic and colovesicular adhesions were noted in 3 of 4 animals. Histologic examination revealed microabscesses at the incision site in all animals. Conclusions: The prototype incision and closure device represents a promising solution to the problems of transluminal access for NOTES. The presence of incision-related adhesions and microabscesses signal the need for further refinement in aseptic technique.