Evidence map›Paper›PMID 24880345›Full record

Trial reportLangenbeck's archives of surgery2014

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).

C Moench, A L Mihaljevic, V Hermanutz, W E Thasler, K Suna, M K Diener, D Seehofer, H J Mischinger, B Jansen-Winkeln, H P Knaebel and 1 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Langenbeck's archives of surgery, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00918619 (Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-bound Fibrin Sealant During Liver Resection), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00918619 phase4completednot on this map

Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-bound Fibrin Sealant During Liver Resection (ESSCALIVER)

TypeinterventionalSponsorAesculap AGRan2010 to 2011Enrolled128ConditionsHemostasis, Liver SurgeryArmsSangustop, Tachosil
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. SPOT GRADE II: Clinical Validation of a New Method for Reproducibly Quantifying Surgical Wound Bleeding: Prospective, Multicenter, Multispecialty, Single-Arm Study.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 2 countries.

C MoenchDepartment of General and Visceral Surgery, Goethe-University Hospital and Clinics, Theodor Stern Kai 7, 60590, Frankfurt am Main, Germany.
A L Mihaljevic
V Hermanutz
W E Thasler
K Suna
M K Diener
D Seehofer
H J Mischinger
B Jansen-Winkeln
H P Knaebel
W O Bechstein
Goethe University Frankfurt · DECharité - Universitätsmedizin Berlin · DEHeidelberg University · DEJohannes Gutenberg University Mainz · DEKlinikum rechts der Isar · DEKrankenhaus Nordwest · DELudwig-Maximilians-Universität München · DEMedical University of Graz · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite 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.

methodsPatients 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.

resultsA 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.

conclusionThe collagen hemostat is as effective as the carrier-bound fibrin sealant in obtaining secondary hemostasis during liver resection with a comparable complication rate.

Indexed as

Hemostasis, SurgicalAgedBlood Loss, SurgicalCollagenFemaleHemostaticsHepatectomyHumansLiver DiseasesMaleMiddle AgedTreatment OutcomeCollagenHemostatics

Identifiers

PMID24880345
PMCPMC4099526
OpenAlexW2138549017

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.