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Bipolar coagulation with the BiClamp® forceps versus conventional suture ligation: a multicenter randomized controlled trial in 175 vaginal hysterectomy patients

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Abstract

Purpose

To compare bipolar vessel sealing (BVS; BiClamp®) versus conventional suture ligation in vaginal hysterectomy.

Methods

A multicenter, single-blind randomized controlled trial (RCT) was conducted at eight women’s hospitals in Germany. One hundred and seventy-five patients with benign uterine disease underwent vaginal hysterectomy using BVS (n = 88) or conventional suture ligation (n = 87 controls). Data analysis was based on intention-to-treat.

Results

Postoperative pain (primary endpoint) was decreased in the BVS group, but not significantly. Intraoperative blood loss was significantly lower in this group, with <100 mL recorded in 79/88 versus 52/86 patients (P < 0.001). Hemoglobin decrease indicated non-significantly lower blood loss in the BVS group. Operating time was significantly shorter in the BVS group than in the controls (38.0 ± 18.6 vs. 48.0 ± 24.9 min; P = 0.001). On average, 7.8 sutures/operation were saved with bipolar coagulation (P < 0.0001). Ease of use ratings were significantly higher for BVS. Hospital stay was similar for both groups. Adverse event rates did not differ significantly.

Conclusions

The BiClamp® procedure proved superior or similar to conventional ligation, particularly with regard to intraoperative blood loss, operating time and postoperative pain, although statistical significance was not attained for postoperative pain. Moreover, BVS was easier to use and more cost effective.

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Acknowledgments

We wish to acknowledge the patients who participated in this study, and our fellow surgeons and hospital staff at the eight participating centers. Funds for trial coordination and monitoring by CenTrial, Tübingen, were kindly provided by ERBE Elektromedizin GmbH, Tübingen, Germany.

Conflict of interest statement

The authors declare that they have no conflict of interest.

Author information

Authors and Affiliations

  1. Department of Obstetrics and Gynecology, University of Tübingen, Calwerstr. 7, 72076, Tübingen, Germany

    Wolfgang Zubke, René Hornung, Sabine Wässerer & Diethelm Wallwiener

  2. Department of Obstetrics and Gynecology, Bethesda Hospital, Wuppertal, Germany

    Jürgen Hucke & Ulrich Füllers

  3. Department of Obstetrics and Gynecology, St. Josef Hospital, Moers, Germany

    Christoph Werner

  4. Department of Obstetrics and Gynecology, Klinikum Stralsund, Stralsund, Germany

    Peter Schmitz

  5. DRK Hospital, Chemnitz-Rabenstein, Germany

    Kurt Lobodasch

  6. Elblandklinikum Radebeul, Radebeul, Germany

    Uwe Hammermüller

  7. Department of Gynecology and Obstetrics, Städtische Kliniken Bielefeld, Bielefeld, Germany

    Richard Wojdat & Joachim Volz

  8. Department of Obstetrics and Gynecology, Pius Hospital, Oldenburg, Germany

    Rudy L. De Wilde

Authors
  1. Wolfgang Zubke
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  2. René Hornung
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  3. Sabine Wässerer
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  7. Peter Schmitz
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  8. Kurt Lobodasch
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  12. Rudy L. De Wilde
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  13. Diethelm Wallwiener
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Corresponding author

Correspondence to Wolfgang Zubke.

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Zubke, W., Hornung, R., Wässerer, S. et al. Bipolar coagulation with the BiClamp® forceps versus conventional suture ligation: a multicenter randomized controlled trial in 175 vaginal hysterectomy patients. Arch Gynecol Obstet 280, 753–760 (2009). https://doi.org/10.1007/s00404-009-1010-7

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  • DOI: https://doi.org/10.1007/s00404-009-1010-7

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