Archives of Gynecology and Obstetrics

, Volume 297, Issue 2, pp 409–414 | Cite as

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

  • M. Hasanov
  • D. Denschlag
  • E. Seemann
  • G. Gitsch
  • J. Woll
  • Maximilian KlarEmail author
General Gynecology



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.


Bipolar vessel sealing Laparoscopy Hysterectomy Costs 


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.

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

Informed consent was obtained from all individual participants included in the study.

Supplementary material

404_2017_4599_MOESM1_ESM.docx (13 kb)
Supplementary material 1 (DOCX 14 kb)


  1. 1.
    Nieboer TE et al (2009) Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev:CD003677.
  2. 2.
    Mäkinen J et al (2001) Morbidity of 10 110 hysterectomies by type of approach. Hum Reprod Oxf Engl 16:1473–1478CrossRefGoogle Scholar
  3. 3.
    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 17:1228–1230CrossRefPubMedGoogle Scholar
  4. 4.
    Alkatout I, Schollmeyer T, Hawaldar NA, Sharma N, Mettler L (2012) Principles and safety measures of electrosurgery in laparoscopy. JSLS 16:130–139CrossRefPubMedPubMedCentralGoogle Scholar
  5. 5.
    Massarweh NN, Cosgriff N, Slakey DP (2006) Electrosurgery: history, principles, and current and future uses. J Am Coll Surg 202:520–530CrossRefPubMedGoogle Scholar
  6. 6.
    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 20:890–894CrossRefPubMedGoogle Scholar
  7. 7.
    Pietrow PK et al (2005) PlasmaKinetic bipolar vessel sealing: burst pressures and thermal spread in an animal model. J Endourol 19:107–110CrossRefPubMedGoogle Scholar
  8. 8.
    Klar M et al (2011) Comparison of a reusable with a disposable vessel-sealing device in a sheep model: efficacy and costs. Fertil Steril 95:795–798CrossRefPubMedGoogle Scholar
  9. 9.
    Chow S-C (2011) Sample size calculations for clinical trials. Wiley Interdiscip Rev Comput Stat 3:414–427CrossRefGoogle Scholar
  10. 10.
    Flordal PA (1997) Measurement of blood loss in clinical studies. Eur J Anaesthesiol Suppl 14:35–37CrossRefPubMedGoogle Scholar
  11. 11.
    Jacoby VL et al (2009) Nationwide use of laparoscopic hysterectomy compared with abdominal and vaginal approaches. Obstet Gynecol 114:1041–1048CrossRefPubMedPubMedCentralGoogle Scholar
  12. 12.
    Wright JD et al (2013) Robotically assisted vs laparoscopic hysterectomy among women with benign gynecologic disease. JAMA 309:689–698CrossRefPubMedGoogle Scholar
  13. 13.
    Wright JD et al (2012) Comparative effectiveness of robotic versus laparoscopic hysterectomy for endometrial cancer. J Clin Oncol 30:783–791CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2017

Authors and Affiliations

  1. 1.Department of Obstetrics and Gynaecology, Freiburg Medical SchoolUniversity of FreiburgFreiburgGermany
  2. 2.Department of Obstetrics and GynaecologyHochtaunus KlinikenBad HomburgGermany

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