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 : 002E32 ( Main/Exploration ); précédent : 002E31; suivant : 002E33A 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
Affiliations:
- Allemagne, Autriche, République tchèque
- Bohême centrale, Vienne (Autriche)
- Prague, Vienne (Autriche)
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Le document en format XML
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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><placeName><region type="land" nuts="2">Vienne (Autriche)</region><settlement type="city">Vienne (Autriche)</settlement></placeName></affiliation></author><author><name sortKey="Polterauer, Stephan" sort="Polterauer, Stephan" uniqKey="Polterauer S" first="Stephan" last="Polterauer">Stephan Polterauer</name><affiliation wicri:level="3"><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><placeName><region type="land" nuts="2">Vienne (Autriche)</region><settlement type="city">Vienne (Autriche)</settlement></placeName></affiliation></author><author><name sortKey="Helmy, Samir" sort="Helmy, Samir" uniqKey="Helmy S" first="Samir" last="Helmy">Samir Helmy</name><affiliation wicri:level="3"><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><placeName><region type="land" nuts="2">Vienne (Autriche)</region><settlement type="city">Vienne (Autriche)</settlement></placeName></affiliation></author><author><name sortKey="Cibula, David" sort="Cibula, David" uniqKey="Cibula D" first="David" last="Cibula">David Cibula</name><affiliation wicri:level="3"><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><placeName><settlement type="city">Prague</settlement><region type="région" nuts="2">Bohême centrale</region></placeName></affiliation></author><author><name sortKey="Zikan, Michal" sort="Zikan, Michal" uniqKey="Zikan M" first="Michal" last="Zikan">Michal Zikan</name><affiliation wicri:level="3"><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><placeName><settlement type="city">Prague</settlement><region type="région" nuts="2">Bohême centrale</region></placeName></affiliation></author><author><name sortKey="Reinthaller, Alexander" sort="Reinthaller, Alexander" uniqKey="Reinthaller A" first="Alexander" last="Reinthaller">Alexander Reinthaller</name><affiliation wicri:level="3"><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><placeName><region type="land" nuts="2">Vienne (Autriche)</region><settlement type="city">Vienne (Autriche)</settlement></placeName></affiliation></author><author><name sortKey="Tempfer, Clemens" sort="Tempfer, Clemens" uniqKey="Tempfer C" first="Clemens" last="Tempfer">Clemens Tempfer</name><affiliation wicri:level="3"><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><placeName><region type="land" nuts="2">Vienne (Autriche)</region><settlement type="city">Vienne (Autriche)</settlement></placeName></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><wicri:noRegion>Bochum</wicri:noRegion><wicri:noRegion>Bochum</wicri:noRegion><wicri:noRegion>Bochum</wicri:noRegion></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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(Autriche)</li></settlement></list><tree><country name="Autriche"><region name="Vienne (Autriche)"><name sortKey="Grimm, Christoph" sort="Grimm, Christoph" uniqKey="Grimm C" first="Christoph" last="Grimm">Christoph Grimm</name></region><name sortKey="Helmy, Samir" sort="Helmy, Samir" uniqKey="Helmy S" first="Samir" last="Helmy">Samir Helmy</name><name sortKey="Polterauer, Stephan" sort="Polterauer, Stephan" uniqKey="Polterauer S" first="Stephan" last="Polterauer">Stephan Polterauer</name><name sortKey="Reinthaller, Alexander" sort="Reinthaller, Alexander" uniqKey="Reinthaller A" first="Alexander" last="Reinthaller">Alexander Reinthaller</name><name sortKey="Tempfer, Clemens" sort="Tempfer, Clemens" uniqKey="Tempfer C" first="Clemens" last="Tempfer">Clemens Tempfer</name></country><country name="République tchèque"><region name="Bohême centrale"><name sortKey="Cibula, David" sort="Cibula, David" uniqKey="Cibula D" first="David" last="Cibula">David Cibula</name></region><name sortKey="Zikan, Michal" sort="Zikan, Michal" uniqKey="Zikan M" first="Michal" last="Zikan">Michal Zikan</name></country><country name="Allemagne"><noRegion><name sortKey="Tempfer, Clemens" sort="Tempfer, Clemens" uniqKey="Tempfer C" first="Clemens" last="Tempfer">Clemens Tempfer</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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|area= LymphedemaV1
|flux= Main
|étape= Exploration
|type= RBID
|clé= PMC:4156659
|texte= A collagen-fibrin patch (Tachosil®) for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies: a randomized clinical trial
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i -Sk "pubmed:25175029" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd \
| NlmPubMed2Wicri -a LymphedemaV1
| This area was generated with Dilib version V0.6.31. |  |