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Vascular clips versus ligatures in thyroid surgery—results of a multicenter randomized controlled trial (CLIVIT Trial)

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Abstract

Background

New techniques using vascular clips or ultrasonically activated shears have been suggested to shorten operation time without compromising safety. The objective of the CLIVIT Trial was to compare ligatures with vascular clips for hemostasis in elective benign thyroid surgery.

Methods

This multicenter, randomized, controlled, parallel group superiority trial was conducted in 13 German surgical centers. Patients scheduled for at least subtotal resection bilaterally were intraoperatively randomized. The primary endpoint was resection time. Secondary endpoints were the amount of postoperative bleeding, reoperation due to bleeding, wound infection, temporary (reversal within 12 months) and permanent (over 1 year) recurrent laryngeal nerve (RLN) paralysis, length of hospital stay, and safety. Registration: ISRCTN 96901396.

Results

Two hundred fifty patients were treated with ligatures and 241 with vascular clips. No differences in patients' baseline and surgical characteristics were observed. No difference was detected for mean resection time (clip 63.5 min ± 29.6, ligature 66.1 min ± 29.3, P = 0.258). Postoperative bleeding (mean 86 ml ± 93), reoperation due to bleeding (clips 4, ligature 2), wound infections (clips 4, ligature 4), postoperative hospital stay (mean 3.0 ± 1.9), and safety data also did not vary significantly. The rates of temporary and permanent RLN paralysis were 6.9 % (34/491) and 2.9 % (14/491), respectively. Not using a surgical drain (123 patients) was not associated with a higher rate of complications.

Conclusion

Vascular clips did not reduce the resection time. However, a 2.9 % rate of permanent RLN paralysis is of concern. Drains in elective surgery may be of no benefit.

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Acknowledgments

We are thankful to the CLIVIT Trial group and the enrolling centers: Ruhan Koc (Universitätsklinikum Heidelberg, 107 patients); Moritz von Frankenberg, Dagmar Anders (Salem Krankenhaus Heidelberg, 105 patients); Karsten Ridwelski, Kathleen Rendel (Klinikum Magdeburg, 51 patients); Thomas Lehnert, Silke Schüle, Evelyn Müller (Klinikum Bremen Mitte, 43 patients); Detlef Bartsch, Katja Maschuw (Universitätsklinikum Marburg, 37 patients); Stefan Riedl, Stefan Hamm, Josef Kuchler (Klinikum am Eichert Göppingen, 35 patients); Joachim Müller, Jens Neudecker (Berlin Charité Campus Mitte, 27 patients); Hans-Peter Bruch, Uwe Roblick, Kathrin Larisch (Universitätsklinikum Schleswig-Holstein, Campus Lübeck, 25 patients); Kaja Ludwig, Uwe Scharlau (Klinikum Süd Rostock, 21 patients); Ernst Thies, Jessica Lange (Klinikum Elmshorn, 18 patients); Heinz J. Buhr, Hubert G Hotz (Berlin Charité Campus Benjamin Franklin, 14 patients); Wolfgang Teichmann, Henning Albrecht (Hamburg Asklepios Klinik Altona, 10 patients); Hans-Detlef Saeger, Achim Hammer, Ralf Konopke (Universitätsklinikum Dresden, 2 patients). We are also grateful to the team at the Study Center of the German Surgical Society (study design: Markus K. Diener, Emre Gazyakan, Boris Fröhlich; study management: Markus K. Diener, Johannes Veit, Alexandra Moreno-Borchart, Inga Wegener) and the team at the Institute for Medical Biometry (study design: Christine Wollermann, Petra Schiller, Andreas Deckert, Steffen Witte, Norbert Victor; data management: Anca Petrisor, Kerstin Pieper, Christiane Klose; study analysis: Thomas Bruckner, Meinhard Kieser).

Funding

The infrastructure of the SDGC is funded by the German Federal Ministry of Education and Research [Bundesministerium für Bildung und Forschung (BMBF); 01GH99033] and the German Surgical Society [Deutsche Gesellschaft für Chirurgie (DGCH)]. Additional industrial funding for the infrastructure has been provided by Johnson & Johnson Medical GmbH, Norderstedt, Germany and Covidien Healthcare Deutschland GmbH, Neustadt, Germany. In addition, this study was funded by a project specific grant from BBD-Aesculap GmbH, Tuttlingen, Germany.

Conflicts of interest

The above-mentioned funding of the infrastructure of the SDGC and the CLIVIT project did not influence the planning, conduct, analysis, interpretation, and reporting of the trial.

C.M. Seiler has received payment for lectures from Aesculap AG, Tuttlingen, Germany. H.P. Knaebel has been employed by Aesculap AG, Tuttlingen, Germany since January 2007. All other authors declare that they have no conflicts of interest.

Preliminary results of this trial were presented on April 21, 2010 at the 127th Annual Meeting of the German Surgical Society, Berlin, Germany.

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Authors and Affiliations

  1. Study Center of the German Surgical Society and Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany

    Markus K. Diener, Christoph M. Seiler, Alexis Ulrich & Markus W. Büchler

  2. Department of Surgery, Salem Hospital Heidelberg, Heidelberg, Germany

    Moritz von Frankenberg

  3. Department of Surgery, Magdeburg General Hospital, Magdeburg, Germany

    Kathleen Rendel

  4. Department of General, Visceral and Oncologic Surgery, Klinikum Bremen-Mitte, Bremen, Germany

    Silke Schüle

  5. Department of Surgery, University of Marburg, Marburg, Germany

    Katja Maschuw & Matthias Rothmund

  6. Department of Surgery, Hospital am Eichert, Göppingen, Germany

    Stefan Riedl

  7. Department of Surgery, Charité Berlin Campus Mitte, Berlin, Germany

    Jens C. Rückert

  8. Department of Surgery, University of Lübeck, Lübeck, Germany

    Christian Eckmann

  9. Department of Surgery, Rostock General Hospital, Rostock, Germany

    Uwe Scharlau

  10. Institute for Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany

    Thomas Bruckner

  11. Aesculap AG, Tuttlingen, Germany

    Hanns-Peter Knaebel

Authors
  1. Markus K. Diener
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  2. Christoph M. Seiler
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  3. Moritz von Frankenberg
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  4. Kathleen Rendel
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  5. Silke Schüle
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  6. Katja Maschuw
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  7. Stefan Riedl
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  8. Jens C. Rückert
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  9. Christian Eckmann
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  10. Uwe Scharlau
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  11. Alexis Ulrich
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  12. Thomas Bruckner
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  13. Hanns-Peter Knaebel
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  14. Matthias Rothmund
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  15. Markus W. Büchler
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for the CLIVIT Study Group

Corresponding author

Correspondence to Markus W. Büchler.

Additional information

Markus K. Diener, Christoph M. Seiler, and Moritz von Frankenberg contributed equally.

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Diener, M.K., Seiler, C.M., von Frankenberg, M. et al. Vascular clips versus ligatures in thyroid surgery—results of a multicenter randomized controlled trial (CLIVIT Trial). Langenbecks Arch Surg 397, 1117–1126 (2012). https://doi.org/10.1007/s00423-012-0976-y

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  • DOI: https://doi.org/10.1007/s00423-012-0976-y

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