Reducing the unexpectedly high rate of injuries caused by NOTES gastrotomy creation.

BACKGROUND: Despite the wide range of natural orifice transluminal endoscopic surgery (NOTES) procedures reported to date using a transgastric endoscopic approach, complications associated with gastrotomy creation have not been described. This study was conducted to identify the incidence and types of complications related to gastrotomy creation with the needle knife puncture and balloon dilatation technique for NOTES access to the peritoneal cavity.
METHODS: Between May 2007 and August 2008, transgastric procedures were performed in 76 swine at a single institution. A total of 58 gastrotomies were created using the needle knife puncture and balloon dilatation technique without laparoscopic observation and 18 gastrotomies were created under laparoscopic visualization after CO(2) insufflation through a laparoscopic port. In all cases, a needle knife with an electrosurgical current of 25-W coagulation and/or 25-W cut and a wire-guided endoscopic balloon dilated to 20 mm were used to create the gastrotomy. All complications were collected prospectively and reviewed from laboratory medical records, operative reports, and necropsy findings.
RESULTS: NOTES gastrotomy-related complications occurred in 10/76 (13.2%) animals. Major complications occurred in six animals (7.9%), including four splenic lacerations, a mesenteric tear, and a fatal diaphragmatic injury. Minor complications occurred in four animals (5.3%), including three abdominal wall injuries and minor gastrotomy site bleeding. When pregastrotomy laparoscopic guidance was used, only one injury occurred in 18 animals (5.5%), but 9/58 (15.5%) gastrotomies performed without laparoscopic visualization caused some type of injury. The difference in rate of injury did not achieve statistical significance. No learning curve effect could be identified.
CONCLUSIONS: Injuries to adjacent viscera occur more often than is reported with the traditional transgastric needle knife NOTES access technique. Gastric punctures should be made either with laparoscopic visualization or by other techniques such as the PEG approach or with noncutting devices to reduce the incidence of visceral injury associated with transgastric peritoneal entry.