A collagen-fibrin patch (Tachosil (R)) for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies: a randomized clinical trial

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00064165:_____/14:10284450

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

A collagen-fibrin patch (Tachosil (R)) for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies: a randomized clinical trial

Popis výsledku v původním jazyce

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

Název v anglickém jazyce

A collagen-fibrin patch (Tachosil (R)) for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies: a randomized clinical trial

Popis výsledku anglicky

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

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FK - Gynekologie a porodnictví

OECD FORD obor

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Projekt

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Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2014

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

BMC Cancer

ISSN

1471-2407

e-ISSN

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Svazek periodika

14

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

7

Strana od-do

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Kód UT WoS článku

000341197500001

EID výsledku v databázi Scopus

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