TY  - JOUR
A1  - Mönch, Christian
A1  - Mihaljevic, Andre L.
A1  - Hermanutz, Valentin
A1  - Thasler, Wolfgang E.
A1  - Suna, Kenan
A1  - Diener, Markus K.
A1  - Seehofer, Daniel
A1  - Mischinger, Hans-Jörg
A1  - Jansen-Winkeln, Boris
A1  - Knaebel, Hanns-Peter
A1  - Bechstein, Wolf Otto
T1  - Randomized controlled multicenter trial on the effectiveness of the collagen hemostat Sangustop compared with a carrier-bound fibrin sealant during liver resection (ESSCALIVER study, NCT00918619)
T2  - Langenbeck's archives of surgery
N2  - Background: Despite improvements in liver surgery over the past decades, hemostasis during hepatic resections remains challenging. This multicenter randomized study compares the hemostatic effect of a collagen hemostat vs. a carrier-bound fibrin sealant after hepatic resection.
Methods: Patients scheduled for elective liver resection were randomized intraoperatively to receive either the collagen hemostat (COLL) or the carrier-bound fibrin sealant (CBFS) for secondary hemostasis. The primary endpoint was the proportion of patients with hemostasis after 3 min. Secondary parameters were the proportions of patients with hemostasis after 5 and 10 min, the total time to hemostasis, and the complication rates during a 3 months follow-up period.
Results: A total of 128 patients were included. In the COLL group, 53 out of 61 patients (86.9 %) achieved complete hemostasis within 3 min after application of the hemostat compared to 52 out of 65 patients (80.0 %) in the CBFS group. The 95 % confidence interval for this difference [−6.0 %, 19.8 %] does not include the lower noninferiority margin (−10 %). Thus, the COLL treatment can be regarded as noninferior to the comparator. The proportions of patients with hemostasis after 3, 5, and 10 min were not significantly different between the two study arms. Postoperative mortality and morbidity were similar in both treatment groups.
Conclusion: The collagen hemostat is as effective as the carrier-bound fibrin sealant in obtaining secondary hemostasis during liver resection with a comparable complication rate.
KW  - Randomized controlled trial
KW  - Liver resection
KW  - Carrier-bound fibrin sealant
KW  - Collagen hemostat
KW  - Hemostatics
Y1  - 2014
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/37358
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-373582
SN  - 1435-2451
SN  - 1435-2443
N1  - Copyright © The Author(s) 2014 Open Access This article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
VL  - 399
IS  - 6
SP  - 725
EP  - 733
PB  - Springer
CY  - Berlin ; Heidelberg
ER  -