Safety profile of trocar and insufflation needle access systems in laparoscopic surgery.
BACKGROUND
The most common laparoscopic complications are associated with trocar insertion. The purpose of this study was to develop an objective method of evaluating the safety profile of various access devices used in laparoscopic surgery.


METHODS
In 20 swine, 6 bladed and 2 needle access devices were evaluated. A force profile was determined by measuring the force required to drive the trocar or needle through the fascia and into the peritoneum, at 0 and 10 mmHg. The amount of tissue deformation, the length of blade exposed, and the duration of exposure were measured using a high-speed digital imaging system.


RESULTS
The needle system without the sheath required the least driving force and had the most favorable force profile. In contrast, the bladed, nonretractable trocar system required a higher driving force and a rapid loss of resistance. Insertion under a pneumoperitoneum did not significantly alter the force profile of the various access devices except for the amount of tissue deformation. With the bladed system, the blade itself was exposed for an average of 0.5 to 1.0 seconds for a distance of 4.5 to 5.0 cm. In comparison, the needle system was exposed for 0.2 seconds for a distance of 1.8 cm.


CONCLUSIONS
We developed a reproducible method of measuring the forces required to place the access systems, their pattern of resistance loss, and the characteristics of the blade exposure. These parameters may provide an adjunctive and objective measurement of safety, allowing for more direct comparison between various trocar designs.
Passerotti
Carlo C
CC
Robotic Research and Training Center, Department of Urology, Children's Hospital Boston and Harvard Medical School, Boston, MA 02115, USA.
Begg
Nikolai
N
Penna
Frank J
FJ
Passerotti
Ana Maria A M S
AM
Leite
Katia R M
KR
Antunes
Alberto Azoubel
AA
Srougi
Miguel
M
Retik
Alan B
AB
Nguyen
Hiep T
HT
D000818:Animals; D004867:Equipment Design; D004869:Equipment Safety; D007431:Intraoperative Complications; D010535:Laparoscopy / Q000379:methods*; D009339:Needles; D011028:Pneumoperitoneum, Artificial / Q000295:instrumentation*; D011312:Pressure; D015203:Reproducibility of Results; D018709:Statistics, Nonparametric; D013525:Surgical Instruments; D013552:Swine