gms | German Medical Science

129. Kongress der Deutschen Gesellschaft für Chirurgie

Deutsche Gesellschaft für Chirurgie

24.04. - 27.04.2012, Berlin

Comparison of the collagen haemostat Sangustop® versus a carrier-bound fibrin sealant during liver resection; An open, randomized, prospective, multicenter, trial

Meeting Abstract

  • Christian Moench - Johann Wolfgang Goethe Universität, Allgemein- und Visceralchirurgie, Frankfurt am Main
  • Moritz Wente - Aesculap AG, Medical Scientific Affairs, Tuttlingen
  • Wolfgang Thasler - Klinikum Großhadern, Chirurgie, München
  • Peter Buechler - TU München, Chirurgie, München
  • Thomas Kraus - Krankenhaus Nordwest, Chirurgie, Frankfurt
  • Christoph Seiler - Johann Wolfgang Goethe Universität, Allgemein- und Visceralchirurgie, Frankfurt am Main
  • Daniel Seehofer - Charite Campus Virchow Klinikum, Allgemein-, Viszeral- und Transplantationschirurgie, Berlin
  • Hans-Joerg Mischinger - Johann Wolfgang Goethe Universität, Allgemein- und Visceralchirurgie, Frankfurt am Main
  • Wolf Otto Bechstein - J.W.Goethe Universität Frankfurt, Klinik für Allgemein- und Viszeralchirurgie, Frankfurt am Main

Deutsche Gesellschaft für Chirurgie. 129. Kongress der Deutschen Gesellschaft für Chirurgie. Berlin, 24.-27.04.2012. Düsseldorf: German Medical Science GMS Publishing House; 2012. Doc12dgch027

DOI: 10.3205/12dgch027, URN: urn:nbn:de:0183-12dgch0270

Veröffentlicht: 23. April 2012

© 2012 Moench et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielfältigt, verbreitet und öffentlich zugänglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Introduction: A new collagen haemostat is expected to be as effective and safe as an established. The aim of this trial was to confirm the non-inferiority of the collagen haemostat Sangustop® versus the carrier-bound fibrin sealant Tachosil® in liver resection.

Material and methods: This trial was designed as an multicenter, randomized, surgical trial with 2 parallel groups. Patients were eligible for intra-operative randomization after elective liver resection and primary hemostasis. The primary end point was the frequency of patients achieving hemostasis after 3 minutes. Secondary endpoints were the frequencies at 5 and 10 minutes. Adverse events were collected to evaluate the safety of treatments.

Results: A total of 127 patients planned for an elective liver resection were enrolled in eight surgical centres. The proportion of patients with haemostasis after 3, 5, and after 10 minutes was not different between the study arm with Sangustop® and the comparator Tachosil®. In the Sangustop® arm 53 out of 61 patients (86.9%) reached haemostasis 3 minutes after application of the product compared to 52 out of 65 patients (80.0 %) in the Tachosil® arm. After 5 minutes the results were 93% vs. 95% and after 10 minutes 98% vs. 100% for Sangustop® and for Tachosil® respectively. Statistical analysis showed that Sangustop® treatment can be regarded as clinically non-inferior to the comparator device Tachosil®. The safety profile of the two tasted treatments were similar.

Conclusion: Sangustop® is not inferior to Tachosil® in obtaining effective intra-operative haemostasis in liver resection. Postoperative morbidity and mortality were similar between both.