Energy-based vessel sealing during vaginal hysterectomy appears to decrease operating time, blood loss, and hospital stay, according to a pair of Canadian researchers.
But one of the two told Reuters Health that the technique isn’t quite ready for prime time.
“Energy-based vessel sealing has the potential to improve operative capability and surgical outcomes,” said Dr. Jamie Kroft from the University of Toronto in an email to Reuters Health. “However, at the present time, there is not enough high quality research that has been performed to justify (the) high cost.”
Energy-based vessel sealing devices use bipolar energy, ultrasonic energy, or nanotechnology to rapid and sequentially seal tissue and vessels; the same hand-held tool is then used for coagulation and transection of the pedicle.
To assess the benefits and complications of these tools in vaginal hysterectomy, Dr. Kroft and Dr. Amanda Selk conducted a systematic review, ultimately studying seven randomized controlled trials involving 662 women. Among the devices tested were the LigaSure, Gyrus PKS Cutting Forcep, Harmonic Scalpel, and Bi Clamp.
The quality of evidence for all outcomes was either low or very low, and there was a suggestion of publication bias.
But as reported this month in Obstetrics & Gynecology, the energy-based vessel sealing devices decreased operative time relative to suturing by 17.2 minutes. The LigaSure device offered the greatest decrease in operative time (22.5 minutes less), whereas the BiClamp device showed no significant decrease in operative time.
The devices were also associated with a significant 47.7 mL decrease in estimated blood loss, and hemoglobin levels declined during surgery by a significant 0.3 g/dL less when sealing devices were used, the authors report.
Hospital stay was 0.25 days shorter in the vessel sealing device group than in the suturing group.
The pooled effect estimate could not rule out a clinically important increase or decrease in the risk of major complications, but postoperative pain was less when LigaSure was used than when BiClamp was used.
“I don’t believe there is strong evidence at the present time based on the systematic review and meta-analysis that energy-based vessel sealing should be recommended because of the low quality of studies included as well as the lack of clinical significance of the outcomes,” Dr. Kroft told Reuters Health.
“Often,” he continued, “new technology becomes popularized because of industry pressure and advertising, although there is no evidence currently to justify the increased cost of using energy-based vessel sealing devices for use in vaginal hysterectomy.”
“I believe it is imperative that we continue to strive to increase the proportion of hysterectomy that is performed in a minimally invasive fashion,” Dr. Kroft added. “If this proves to be a safe option as compared to the traditional technique, then future research is needed to determine if the ease of performing the procedure is (maximized) by using this technology. This may increase both the proportion and complexity of cases that can be performed vaginally. If that is the case, the increase in cost of the device may be negligible compared to the cost savings and patient benefits that would be incurred by decreasing the proportion of abdominal hysterectomy.”
Obstet Gynecol 2011;118:1127-1136.
— Will Boggs MD