Bipolar vessel – sealing devices in laparoscopic hysterectomies: a multicentre randomised controlled clinical trial
20 September 2018 (online)
Total laparoscopic hysterectomies (TLH) lead to a lower intraoperative blood loss and a shorter hospital stay compared with total abdominal hysterectomies (AH). The evolution of TLH is closely linked to the continuous visual and electrosurgical progress. The aim of this trial was to compare the reusable Marseal™ IQ 5 mm (MS) and the disposable Ligasure™ 5 mm (LS) devices with regards to operating time, reliability and safety in patients undergoing LH for benign gynaecological diseases.
A randomised controlled clinical trial (RCT) in two German gynecology departments. 74 patients scheduled to undergo TLH for a symptomatic fibroid uterus, adenomyosis or severe meno-metrorrhagia were randomised to receive a TLH with either the MS or the LS device. 27 variables were prospectively collected to address potential confounding issues.
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 = 0.89). 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 = 0.36).
Both devices provided reliable and effective sealing and dissection. The reusable MS showed non-inferiority against the disposable LS device with regards to operating time and estimated intraoperative blood loss.