A collagen-fibrin patch (Tachosil®) for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies: a randomized clinical trial
Identifieur interne : 000C15 ( Pmc/Curation ); précédent : 000C14; suivant : 000C16A collagen-fibrin patch (Tachosil®) for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies: a randomized clinical trial
Auteurs : Christoph Grimm [Autriche] ; Stephan Polterauer [Autriche] ; Samir Helmy [Autriche] ; David Cibula [République tchèque] ; Michal Zikan [République tchèque] ; Alexander Reinthaller [Autriche] ; Clemens Tempfer [Autriche, Allemagne]Source :
- BMC Cancer [ 1471-2407 ] ; 2014.
Abstract
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®) is effective in the prevention of symptomatic lymphoceles after pelvic lymphadenectomy.
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® 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 patients per group was calculated to detect a 66% absolute decrease in symptomatic lymphoceles.
We aim to provide further evidence for the efficacy of a collagen-fibrin patch in the prevention of symptomatic lymphoceles in women with gynecological malignancies undergoing pelvic lymphadenectomy.
This study is registered at ClinicalTrials.gov (
Url:
DOI: 10.1186/1471-2407-14-635
PubMed: 25175029
PubMed Central: 4156659
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">A collagen-fibrin patch (Tachosil®) for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies: a randomized clinical trial</title><author><name sortKey="Grimm, Christoph" sort="Grimm, Christoph" uniqKey="Grimm C" first="Christoph" last="Grimm">Christoph Grimm</name><affiliation wicri:level="1"><nlm:aff id="Aff9">Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria</nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna</wicri:regionArea></affiliation></author><author><name sortKey="Polterauer, Stephan" sort="Polterauer, Stephan" uniqKey="Polterauer S" first="Stephan" last="Polterauer">Stephan Polterauer</name><affiliation wicri:level="1"><nlm:aff id="Aff9">Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria</nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna</wicri:regionArea></affiliation></author><author><name sortKey="Helmy, Samir" sort="Helmy, Samir" uniqKey="Helmy S" first="Samir" last="Helmy">Samir Helmy</name><affiliation wicri:level="1"><nlm:aff id="Aff9">Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria</nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna</wicri:regionArea></affiliation></author><author><name sortKey="Cibula, David" sort="Cibula, David" uniqKey="Cibula D" first="David" last="Cibula">David Cibula</name><affiliation wicri:level="1"><nlm:aff id="Aff10">Department of Obstetrics and Gynecology, Gynecologic Oncology Center, Charles University in Prague, Prague, Czech Republic</nlm:aff><country xml:lang="fr">République tchèque</country><wicri:regionArea>Department of Obstetrics and Gynecology, Gynecologic Oncology Center, Charles University in Prague, Prague</wicri:regionArea></affiliation></author><author><name sortKey="Zikan, Michal" sort="Zikan, Michal" uniqKey="Zikan M" first="Michal" last="Zikan">Michal Zikan</name><affiliation wicri:level="1"><nlm:aff id="Aff10">Department of Obstetrics and Gynecology, Gynecologic Oncology Center, Charles University in Prague, Prague, Czech Republic</nlm:aff><country xml:lang="fr">République tchèque</country><wicri:regionArea>Department of Obstetrics and Gynecology, Gynecologic Oncology Center, Charles University in Prague, Prague</wicri:regionArea></affiliation></author><author><name sortKey="Reinthaller, Alexander" sort="Reinthaller, Alexander" uniqKey="Reinthaller A" first="Alexander" last="Reinthaller">Alexander Reinthaller</name><affiliation wicri:level="1"><nlm:aff id="Aff9">Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria</nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna</wicri:regionArea></affiliation></author><author><name sortKey="Tempfer, Clemens" sort="Tempfer, Clemens" uniqKey="Tempfer C" first="Clemens" last="Tempfer">Clemens Tempfer</name><affiliation wicri:level="1"><nlm:aff id="Aff9">Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria</nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff11">Department of Obstetrics and Gynecology, Ruhr University Bochum, Bochum, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Obstetrics and Gynecology, Ruhr University Bochum, Bochum</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25175029</idno><idno type="pmc">4156659</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4156659</idno><idno type="RBID">PMC:4156659</idno><idno type="doi">10.1186/1471-2407-14-635</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">000C16</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000C16</idno><idno type="wicri:Area/Pmc/Curation">000C15</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000C15</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A collagen-fibrin patch (Tachosil®) for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies: a randomized clinical trial</title><author><name sortKey="Grimm, Christoph" sort="Grimm, Christoph" uniqKey="Grimm C" first="Christoph" last="Grimm">Christoph Grimm</name><affiliation wicri:level="1"><nlm:aff id="Aff9">Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria</nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna</wicri:regionArea></affiliation></author><author><name sortKey="Polterauer, Stephan" sort="Polterauer, Stephan" uniqKey="Polterauer S" first="Stephan" last="Polterauer">Stephan Polterauer</name><affiliation wicri:level="1"><nlm:aff id="Aff9">Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria</nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna</wicri:regionArea></affiliation></author><author><name sortKey="Helmy, Samir" sort="Helmy, Samir" uniqKey="Helmy S" first="Samir" last="Helmy">Samir Helmy</name><affiliation wicri:level="1"><nlm:aff id="Aff9">Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria</nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna</wicri:regionArea></affiliation></author><author><name sortKey="Cibula, David" sort="Cibula, David" uniqKey="Cibula D" first="David" last="Cibula">David Cibula</name><affiliation wicri:level="1"><nlm:aff id="Aff10">Department of Obstetrics and Gynecology, Gynecologic Oncology Center, Charles University in Prague, Prague, Czech Republic</nlm:aff><country xml:lang="fr">République tchèque</country><wicri:regionArea>Department of Obstetrics and Gynecology, Gynecologic Oncology Center, Charles University in Prague, Prague</wicri:regionArea></affiliation></author><author><name sortKey="Zikan, Michal" sort="Zikan, Michal" uniqKey="Zikan M" first="Michal" last="Zikan">Michal Zikan</name><affiliation wicri:level="1"><nlm:aff id="Aff10">Department of Obstetrics and Gynecology, Gynecologic Oncology Center, Charles University in Prague, Prague, Czech Republic</nlm:aff><country xml:lang="fr">République tchèque</country><wicri:regionArea>Department of Obstetrics and Gynecology, Gynecologic Oncology Center, Charles University in Prague, Prague</wicri:regionArea></affiliation></author><author><name sortKey="Reinthaller, Alexander" sort="Reinthaller, Alexander" uniqKey="Reinthaller A" first="Alexander" last="Reinthaller">Alexander Reinthaller</name><affiliation wicri:level="1"><nlm:aff id="Aff9">Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria</nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna</wicri:regionArea></affiliation></author><author><name sortKey="Tempfer, Clemens" sort="Tempfer, Clemens" uniqKey="Tempfer C" first="Clemens" last="Tempfer">Clemens Tempfer</name><affiliation wicri:level="1"><nlm:aff id="Aff9">Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria</nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff11">Department of Obstetrics and Gynecology, Ruhr University Bochum, Bochum, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Obstetrics and Gynecology, Ruhr University Bochum, Bochum</wicri:regionArea></affiliation></author></analytic><series><title level="j">BMC Cancer</title><idno type="eISSN">1471-2407</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>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®) is effective in the prevention of symptomatic lymphoceles after pelvic lymphadenectomy.</p></sec><sec><title>Methods/Design</title><p>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® 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 patients per group was calculated to detect a 66% absolute decrease in symptomatic lymphoceles.</p></sec><sec><title>Discussion</title><p>We aim to provide further evidence for the efficacy of a collagen-fibrin patch in the prevention of symptomatic lymphoceles in women with gynecological malignancies undergoing pelvic lymphadenectomy.</p></sec><sec><title>Trial registration</title><p>This study is registered at ClinicalTrials.gov (<ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov/ct2/show/NCT01470677">NCT01470677</ext-link>, protocol ID: TACHO-1). This study is registered at the EudraCT database (EudraCT number: 2011-003115-34).</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="O Anlan, Ka" uniqKey="O Anlan K">KA O’Hanlan</name></author><author><name sortKey="Pinto, Ra" uniqKey="Pinto R">RA Pinto</name></author><author><name sortKey="O Olleran, M" uniqKey="O Olleran M">M O’Holleran</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Marchiole, P" uniqKey="Marchiole P">P Marchiole</name></author><author><name sortKey="Benchaib, M" uniqKey="Benchaib M">M Benchaib</name></author><author><name sortKey="Buenerd, A" uniqKey="Buenerd A">A Buenerd</name></author><author><name sortKey="Lazlo, E" uniqKey="Lazlo E">E Lazlo</name></author><author><name sortKey="Dargent, D" uniqKey="Dargent D">D Dargent</name></author><author><name sortKey="Mathevet, P" uniqKey="Mathevet P">P 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<front><journal-meta><journal-id journal-id-type="nlm-ta">BMC Cancer</journal-id><journal-id journal-id-type="iso-abbrev">BMC Cancer</journal-id><journal-title-group><journal-title>BMC Cancer</journal-title></journal-title-group><issn pub-type="epub">1471-2407</issn><publisher><publisher-name>BioMed Central</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">25175029</article-id><article-id pub-id-type="pmc">4156659</article-id><article-id pub-id-type="publisher-id">4809</article-id><article-id pub-id-type="doi">10.1186/1471-2407-14-635</article-id><article-categories><subj-group subj-group-type="heading"><subject>Study Protocol</subject></subj-group></article-categories><title-group><article-title>A collagen-fibrin patch (Tachosil®) for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies: a randomized clinical trial</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Grimm</surname><given-names>Christoph</given-names></name><address><email>christoph.grimm@meduniwien.ac.at</email></address><xref ref-type="aff" rid="Aff9"></xref></contrib><contrib contrib-type="author"><name><surname>Polterauer</surname><given-names>Stephan</given-names></name><address><email>stephan.polterauer@meduniwien.ac.at</email></address><xref ref-type="aff" rid="Aff9"></xref></contrib><contrib contrib-type="author"><name><surname>Helmy</surname><given-names>Samir</given-names></name><address><email>samir.helmy@meduniwien.ac.at</email></address><xref ref-type="aff" rid="Aff9"></xref></contrib><contrib contrib-type="author"><name><surname>Cibula</surname><given-names>David</given-names></name><address><email>d.cibula@yahoo.com</email></address><xref ref-type="aff" rid="Aff10"></xref></contrib><contrib contrib-type="author"><name><surname>Zikan</surname><given-names>Michal</given-names></name><address><email>michal.zikan@lf1.cuni.cz</email></address><xref ref-type="aff" rid="Aff10"></xref></contrib><contrib contrib-type="author"><name><surname>Reinthaller</surname><given-names>Alexander</given-names></name><address><email>alexander.reinthaller@meduniwien.ac.at</email></address><xref ref-type="aff" rid="Aff9"></xref></contrib><contrib contrib-type="author"><name><surname>Tempfer</surname><given-names>Clemens</given-names></name><address><email>clemens.tempfer@marienhospital-herne.de</email></address><xref ref-type="aff" rid="Aff9"></xref><xref ref-type="aff" rid="Aff11"></xref></contrib><aff id="Aff9"><label></label>Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria</aff><aff id="Aff10"><label></label>Department of Obstetrics and Gynecology, Gynecologic Oncology Center, Charles University in Prague, Prague, Czech Republic</aff><aff id="Aff11"><label></label>Department of Obstetrics and Gynecology, Ruhr University Bochum, Bochum, Germany</aff></contrib-group><pub-date pub-type="epub"><day>30</day><month>8</month><year>2014</year></pub-date><pub-date pub-type="pmc-release"><day>30</day><month>8</month><year>2014</year></pub-date><pub-date pub-type="collection"><year>2014</year></pub-date><volume>14</volume><elocation-id>635</elocation-id><history><date date-type="received"><day>9</day><month>1</month><year>2014</year></date><date date-type="accepted"><day>22</day><month>8</month><year>2014</year></date></history><permissions><copyright-statement>© Grimm et al.; licensee BioMed Central Ltd. 2014</copyright-statement><license license-type="open-access"><license-p>This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/2.0">http://creativecommons.org/licenses/by/2.0</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>) applies to the data made available in this article, unless otherwise stated.</license-p></license></permissions><abstract id="Abs1"><sec><title>Background</title><p>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®) is effective in the prevention of symptomatic lymphoceles after pelvic lymphadenectomy.</p></sec><sec><title>Methods/Design</title><p>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® 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 patients per group was calculated to detect a 66% absolute decrease in symptomatic lymphoceles.</p></sec><sec><title>Discussion</title><p>We aim to provide further evidence for the efficacy of a collagen-fibrin patch in the prevention of symptomatic lymphoceles in women with gynecological malignancies undergoing pelvic lymphadenectomy.</p></sec><sec><title>Trial registration</title><p>This study is registered at ClinicalTrials.gov (<ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov/ct2/show/NCT01470677">NCT01470677</ext-link>, protocol ID: TACHO-1). This study is registered at the EudraCT database (EudraCT number: 2011-003115-34).</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>Collagen-fibrin patch</kwd><kwd>Tachosil</kwd><kwd>Lymphocele</kwd><kwd>Pelvic lymphadenectomy</kwd><kwd>Gynecological malignancy</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© The Author(s) 2014</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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