Reduction of Cannula-Related Laparoscopic Complications Using a Radially Expanding Access Device: A review of 541 Step Cannula Placements with Virtual Absence of Complications

D.I. Galen, A Jacobson, L.N. Weckstein, R.A. Kaplan, K.L. deNevi 

Reproductive Science Center® of the San Francisco Bay Area 
 

Until recently, access to the abdominal cavity for laparoscopic procedures has required the use of sharp trocars (ST). Despite careful placement by experienced surgeons, ST-related complications have, and continue to be a serious, sometimes life-threatening problem. In 1994, a new patented (StepŠ) access design became available which uses a Veres needle for placement, a radially dilating expandable sleeve, and a blunt dilator and cannula. Laparoscopic insertion of 541 radially dilating (RD) cannulas by 5 surgeons at 6 different sites has not resulted in a single case of abdominal vascular injury, bowel injury, or incisional hernia (95% CI, 0.0%-0.6%). These results are significantly different (p<0.05) from the expected cumulative rate of 1% or greater observed in published series. With this new RD system, complication rates have been significantly reduced, operative times shortened and cost savings have been realized. The FDA granted clearance to the manufacturer (Innerdyne, Inc.) to market the StepŠ radially dilating abdominal access device as having increased safety and performance as compared to sharp trocar systems. This new design reduced laparoscopic complications, lessens a surgeon's exposure to liability, and improves patient outcomes.

Copyright 2000-2005 Donald I. Galen, M.D. 
Physician partner in the Reproductive Science CenterŠ of the San Francisco Bay Area
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