Bipolar vessel-sealing devices in laparoscopic hysterectomies: a multicenter randomized controlled clinical trial
This RCT found that the reusable MS and disposable LS vessel-sealing devices were non-inferior in operating time and estimated blood loss during laparoscopic hysterectomies.
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This multicenter randomized controlled clinical trial compared the Marseal™ 5 mm bipolar vessel-sealing device (MS) with the Ligasure™ 5 mm device (LS) during total laparoscopic hysterectomy (TLH) for benign indications (symptomatic fibroid uterus, adenomyosis, or severe meno-metrorrhagia) in 74 women across two German gynecology departments, with 27 prospective variables collected to address confounding. Operating time and intraoperative blood loss were measured between the first and last device uses, and mean operating time (22.7 min for LS vs 26.4 min for MS) and estimated blood loss (164 ml vs 160 ml) did not differ significantly; multivariate analyses adjusting for BMI, endometriosis, uterine weight, and fibroid appearance also found no significant device effect. The reusable MS was reported as non-inferior to the disposable LS for operating time and estimated blood loss, with the main limitation being that outcomes were based on estimated blood loss and the study context was limited to TLH for specific benign conditions. Relevance to endometriosis: the trial includes endometriosis as an adjusted confounder in multivariate analyses, though the devices were studied for TLH indications that also included adenomyosis.
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