DI Galen, M.D., A Jacobson, M.D., LN Weckstein, M.D., JS Rasor
This study conducted by the Reproductive Science Centerª of the San Francisco Bay Area
A retrospective study was performed to compare the complication rate, effectiveness, and cost of a new radially expandable access device (InnerDyne STEP) and conventional trocar access devices (control devices, Ethicon, USS, Apple, Origin, Allen) used in laparoscopic surgery. Twenty-one surgeons at seven sites performed one of six common laparoscopic surgical procedures inserting 391 access devices (136 test and 255 control devices) into 130 patients. The six laparoscopic procedures performed were Laparoscopic hysterectomy and removal of both tubes and ovaries (LAVH/BSO), Laparoscopic hysterectomy (LAVH), LAVH/D&C, adhesiolysis, fulguration and inguinal hernia repair.
The patient population demographics for all surgeries were not significantly different between the device groups. The data were evaluated by both blocking and pooling the surgical procedures using the Wilcoxon Rank Sum Test.
The complication rate was significantly lower for the test device 0.7% vs. the control device 7.0% (p=0.005); the rate by patient was 2% and 10% (p=0.035) respectively. The optimally weighted blocked surgery time combined across all six procedure groups was significantly shorter for the test device (p=0.0001) and the pooled result was also highly significant (p=0.0043) in favor of the test device. Surgery time for the largest group (LAVH/BSO) averaged 96 minutes for the test device and 128 minutes for the control device (p=0.0021), resulting in a cost savings of $1,467.50/patient. The estimated blood loss was less for the test device vs. the control device (137 vs 244 ml, p=0.058).
In summary, the test device significantly reduces risks associated with sharp trocars; it punctures and dilates rather than cuts minimizing tissue trauma (abdominal wall bleeding rate = 0% vs. 3%), tamponades blood vessels for hemostasis as evidenced by a lower bleeding rate and estimated blood loss, leaves a smaller wound that does not require fascial closure, firmly anchors the cannula in place due to radial traction (slippage rate = 0% vs. 3%), permits expansion of the access port from 5 mm to a 10 mm or 12 mm working channel, and reduces costs of procedures.
Study presented at the:
Copyright 2000-2005 Donald I. Galen, M.D.
Physician partner in the Reproductive
Science Centerª of the San Francisco Bay Area
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