INTRODUCTION: 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 AND PROCEDURES: Between May 2007 and August 2008, 113 NOTES experiments were performed at a single institution with transgastric endoscopic access achieved in 76 animals. 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 CO2 insufflations through a laparoscopic port. In all cases, a needle knife (Cook Medical Inc., Winston-Salem, NC) with an electrosurgical current of 25W coagulation and/or 25W cut and a CRE balloon (Boston Scientific, Natick, MA) dilated to 20mm 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 6 animals (7.9%), including 4 splenic lacerations, a mesenteric tear and a fatal diaphragmatic injury. Minor complications occurred in 4 animals (5.3%), including three abdominal wall injuries and minor gastrotomy site bleeding. When pre-gastrotomy 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 types of injury. The difference although seemingly meaningful did not achieve statistical significance. No learning curve affect could be identified.
CONCLUSION: 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 non-cutting devices to reduce the incidence of visceral injury associated with transgastric peritoneal entry.
Session: Podium Presentation
Program Number: S082