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

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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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Abstract

ObjectiveTo 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 settingA randomized controlled clinical trial (RCT) in two German gynecology departments.Patients74 patients scheduled to undergo TLH for a symptomatic fibroid uterus, adenomyosis or severe meno-metrorrhagia.InterventionsPatients 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 resultsOperating 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.ConclusionIn 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.
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Abstract

Objective 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. 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. Similar content being viewed by others

References

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 Mäkinen J et al (2001) Morbidity of 10 110 hysterectomies by type of approach. Hum Reprod Oxf Engl 16:1473–1478 Harold KL et al (2003) Comparison of ultrasonic energy, bipolar thermal energy, and vascular clips for the hemostasis of small-, medium-, and large-sized arteries. Surg Endosc 17:1228–1230 Alkatout I, Schollmeyer T, Hawaldar NA, Sharma N, Mettler L (2012) Principles and safety measures of electrosurgery in laparoscopy. JSLS 16:130–139 Massarweh NN, Cosgriff N, Slakey DP (2006) Electrosurgery: history, principles, and current and future uses. J Am Coll Surg 202:520–530 Richter S, Kollmar O, Schilling MK, Pistorius GA, Menger MD (2006) Efficacy and quality of vessel sealing: comparison of a reusable with a disposable device and effects of clamp surface geometry and structure. Surg Endosc 20:890–894 Pietrow PK et al (2005) PlasmaKinetic bipolar vessel sealing: burst pressures and thermal spread in an animal model. J Endourol 19:107–110 Klar M et al (2011) Comparison of a reusable with a disposable vessel-sealing device in a sheep model: efficacy and costs. Fertil Steril 95:795–798 Chow S-C (2011) Sample size calculations for clinical trials. Wiley Interdiscip Rev Comput Stat 3:414–427 Flordal PA (1997) Measurement of blood loss in clinical studies. Eur J Anaesthesiol Suppl 14:35–37 Jacoby VL et al (2009) Nationwide use of laparoscopic hysterectomy compared with abdominal and vaginal approaches. Obstet Gynecol 114:1041–1048 Wright JD et al (2013) Robotically assisted vs laparoscopic hysterectomy among women with benign gynecologic disease. JAMA 309:689–698 Wright JD et al (2012) Comparative effectiveness of robotic versus laparoscopic hysterectomy for endometrial cancer. J Clin Oncol 30:783–791 Author information Authors and Affiliations Contributions Author contributions 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. Corresponding author Ethics declarations Funding 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 Informed consent was obtained from all individual participants included in the study. Electronic supplementary material Below is the link to the electronic supplementary material. Rights and permissions About this article Cite this article Hasanov, M., Denschlag, D., Seemann, E. et al. Bipolar vessel-sealing devices in laparoscopic hysterectomies: a multicenter randomized controlled clinical trial. Arch Gynecol Obstet 297, 409–414 (2018). https://doi.org/10.1007/s00404-017-4599-y Received: Accepted: Published: Issue date: DOI: https://doi.org/10.1007/s00404-017-4599-y

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Condition tags

endometriosis

MeSH descriptors

Endometriosis Hysterectomy Laparoscopy Leiomyoma Adult Blood Loss, Surgical Endometriosis Female Humans Laparoscopy Laparoscopy Leiomyoma Middle Aged Operative Time Uterus Uterus

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