Bipolar vessel-sealing devices in laparoscopic hysterectomies: a multicenter randomized controlled clinical trial
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To compare operating time and blood loss in patients undergoing total laparoscopic hysterectomies (TLH) for benign conditions with either the Marseal™ IQ 5 mm (MS) or the Ligasure™ 5 mm (LS) vessel-sealing device.
Design and setting
A randomized 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.
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.
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.
KeywordsBipolar vessel sealing Laparoscopy Hysterectomy Costs
HMF: data collection, data accuracy, data management. DD: study concept, data analysis, manuscript writing, manuscript editing. SE: principal surgeon II, data collection, data accuracy, data management. GG: study concept, manuscript editing. WJ: principal surgeon I, manuscript editing. KM: study concept, data analysis, manuscript writing, manuscript editing.
Compliance with ethical standards
Institutional funding for this study was provided by KLS Martin.
Conflict of interest
GG and DD receive payments for an annual KLS Martin advisory board meeting. MH, MK, ES and JW declare no conflict of interest.
Research involving human participants
All procedures performed were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
- 1.Nieboer TE et al (2009) Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev:CD003677. https://doi.org/10.1002/14651858.CD003677.pub4