Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria. firstname.lastname@example.org.
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).