Published in:
Open Access 01-12-2014 | 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
Published in: BMC Cancer | Issue 1/2014
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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).