A collagen-fibrin patch (Tachosil (R)) for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies: a randomized clinical trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F14%3A10284450" target="_blank" >RIV/00216208:11110/14:10284450 - isvavai.cz</a>
Alternative codes found
RIV/00064165:_____/14:10284450
Result on the web
<a href="http://dx.doi.org/10.1186/1471-2407-14-635" target="_blank" >http://dx.doi.org/10.1186/1471-2407-14-635</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1186/1471-2407-14-635" target="_blank" >10.1186/1471-2407-14-635</a>
Alternative languages
Result language
angličtina
Original language name
A collagen-fibrin patch (Tachosil (R)) for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies: a randomized clinical trial
Original language description
Background: Lymphoceles are a common complication after pelvic lymphadenectomy in women with gynecologic malignancies. Although typically asymptomatic, lymphoceles can superinfect requiring medical or surgical intervention. A single center randomized controlled trial provided first evidence, that a collagen-fibrin patch (Tachosil (R)) is effective in the prevention of symptomatic lymphoceles after pelvic lymphadenectomy. Methods/Design: We will perform a multicentre, blinded, randomized, controlled trial comprising 140 women with gynecologic malignancies undergoing pelvic lymphadenectomy. Women will be randomly allocated to Tachosil (R) application or no application. Primary outcome is efficacy, defined as lymphocele CTCAE 4.03 grade }= 2 within four weeks after surgery. Secondary outcomes are asymptomatic lymphocele verified by ultrasound, medical or surgical intervention. Assuming a two-sided 5% significance level, a power of 80%, and a drop out rate of 10%, a sample size of 68 patie
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FK - Gynaecology and obstetrics
OECD FORD branch
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Result continuities
Project
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Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2014
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
BMC Cancer
ISSN
1471-2407
e-ISSN
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Volume of the periodical
14
Issue of the periodical within the volume
1
Country of publishing house
GB - UNITED KINGDOM
Number of pages
7
Pages from-to
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UT code for WoS article
000341197500001
EID of the result in the Scopus database
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