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

Christoph Grimm, Stephan Polterauer, Samir Helmy, David Cibula, Michal Zikan, Alexander Reinthaller, Clemens Tempfer, Christoph Grimm, Stephan Polterauer, Samir Helmy, David Cibula, Michal Zikan, Alexander Reinthaller, Clemens Tempfer

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).

Figures

Figure 1
Figure 1
Right pelvic side wall after systematic pelvic lymphadenectomy. 1 = Right external iliac artery. 2 = Right internal iliac artery, 3 = Right obturator nerve.
Figure 2
Figure 2
Tachosil® is applied with a wet glove and sponge and compression for 30–60 seconds. Thereafter glove and sponge are removed.
Figure 3
Figure 3
Placement of the first Tachosil patch in the right obturator fossa. 1 = Right external iliac artery. 2 = Right internal iliac artery.

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Pre-publication history
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