Bipolar vessel-sealing devices in laparoscopic hysterectomies: a multicenter randomized controlled clinical trial.

Hasanov, M; Denschlag, D; Seemann, E; Gitsch, G; Woll, J; Klar, Maximilian

OBJECTIVE To compare operating time and blood loss in patients undergoing total laparoscopic hysterectomies (TLH) for benign conditions with either the Marsealâ„¢ IQ 5 mm (MS) or the Ligasureâ„¢ 5 mm (LS) vessel-sealing device. DESIGN AND SETTING A randomized controlled clinical trial (RCT) in two German gynecology departments. PATIENTS 74 patients scheduled to undergo TLH for a symptomatic fibroid uterus, adenomyosis or severe meno-metrorrhagia. INTERVENTIONS Patients were randomized to receive a TLH with either the MS or the LS device. 27 variables were prospectively collected to address potential confounding issues. MEASUREMENT AND MAIN RESULTS Operating time, defined as the time period between the first (round ligament dissection) and the last (uterine vessels sealing) use of the device, estimated and calculated intraoperative blood loss. The mean operating time (95% confidence interval, CI) was 22.7 min (95% CI 17.6-27.7) for LS and 26.4 min (95% CI 20-32.8) for the MS device (p = .89). The estimated intraoperative blood loss was 164 ml (95% CI 110-217) for LS and 160 ml (95% CI 116-203) for the MS device (p = .36). The multivariate analyses accounting for BMI, endometriosis, uterine weight and appearance of fibroids did not reveal any significant effect of the type of device used on operating time and estimated blood loss. CONCLUSION In this RCT, both devices provided reliable and effective sealing and dissection. The reusable MS showed non-inferiority against the disposable LS device with regard to operating time and estimated intraoperative blood loss.