{"paper_id":"5450d9cc-711e-4bad-b330-e8f9b216b7f4","body_text":"Abstract\nObjective\nTo 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.\nDesign and setting\nA randomized controlled clinical trial (RCT) in two German gynecology departments.\nPatients\n74 patients scheduled to undergo TLH for a symptomatic fibroid uterus, adenomyosis or severe meno-metrorrhagia.\nInterventions\nPatients were randomized to receive a TLH with either the MS or the LS device. 27 variables were prospectively collected to address potential confounding issues.\nMeasurement and main results\nOperating 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.\nConclusion\nIn 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.\nSimilar content being viewed by others\nReferences\nNieboer 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\nMäkinen J et al (2001) Morbidity of 10 110 hysterectomies by type of approach. Hum Reprod Oxf Engl 16:1473–1478\nHarold 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\nAlkatout I, Schollmeyer T, Hawaldar NA, Sharma N, Mettler L (2012) Principles and safety measures of electrosurgery in laparoscopy. JSLS 16:130–139\nMassarweh NN, Cosgriff N, Slakey DP (2006) Electrosurgery: history, principles, and current and future uses. J Am Coll Surg 202:520–530\nRichter 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\nPietrow PK et al (2005) PlasmaKinetic bipolar vessel sealing: burst pressures and thermal spread in an animal model. J Endourol 19:107–110\nKlar 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\nChow S-C (2011) Sample size calculations for clinical trials. Wiley Interdiscip Rev Comput Stat 3:414–427\nFlordal PA (1997) Measurement of blood loss in clinical studies. Eur J Anaesthesiol Suppl 14:35–37\nJacoby VL et al (2009) Nationwide use of laparoscopic hysterectomy compared with abdominal and vaginal approaches. Obstet Gynecol 114:1041–1048\nWright JD et al (2013) Robotically assisted vs laparoscopic hysterectomy among women with benign gynecologic disease. JAMA 309:689–698\nWright JD et al (2012) Comparative effectiveness of robotic versus laparoscopic hysterectomy for endometrial cancer. J Clin Oncol 30:783–791\nAuthor information\nAuthors and Affiliations\nContributions\nAuthor contributions\nHMF: 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.\nCorresponding author\nEthics declarations\nFunding\nInstitutional funding for this study was provided by KLS Martin.\nConflict of interest\nGG and DD receive payments for an annual KLS Martin advisory board meeting. MH, MK, ES and JW declare no conflict of interest.\nResearch involving human participants\nAll 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.\nInformed consent\nInformed consent was obtained from all individual participants included in the study.\nElectronic supplementary material\nBelow is the link to the electronic supplementary material.\nRights and permissions\nAbout this article\nCite this article\nHasanov, 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\nReceived:\nAccepted:\nPublished:\nIssue date:\nDOI: https://doi.org/10.1007/s00404-017-4599-y","source_license":"CC0","license_restricted":false}