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Open Access Highly Accessed Study protocol

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

Christoph Grimm1*, Stephan Polterauer1, Samir Helmy1, David Cibula2, Michal Zikan2, Alexander Reinthaller1 and Clemens Tempfer13

Author Affiliations

1 Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria

2 Department of Obstetrics and Gynecology, Gynecologic Oncology Center, Charles University in Prague, Prague, Czech Republic

3 Department of Obstetrics and Gynecology, Ruhr University Bochum, Bochum, Germany

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BMC Cancer 2014, 14:635  doi:10.1186/1471-2407-14-635

Published: 30 August 2014

Abstract

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®) 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® 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.

Discussion

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.

Trial registration

This study is registered at ClinicalTrials.gov (NCT01470677, protocol ID: TACHO-1). This study is registered at the EudraCT database (EudraCT number: 2011-003115-34).

Keywords:
Collagen-fibrin patch; Tachosil; Lymphocele; Pelvic lymphadenectomy; Gynecological malignancy