Efficacy of a fibrin sealant (Tissucol Duo®) for the prevention of lymphocele after laparoscopic pelvic lymphadenectomy: a randomised controlled trial

ABSTRACT Study Objective To assess the efficacy of Tissucol Duo® (Baxter AG) fibrin sealant in decreasing the incidence of lymphocele (LC) after pelvic laparoscopic lymph node dissection using harmonic shears. Design classification Randomized controlled trial (Canadian Task Force Classification level I) Setting Tertiary referral and educational center. Patients A double blind randomized controlled study was conducted (February 2012-June 2016) including 74 patients randomizing the use of sealant per hemipelvis. Intervention Following bilateral pelvic lymphadenectomy, a fibrin sealant was used in one hemipelvis but not the other, being applied in 41 (55.4%) left and 33 (44.6%) right hemipelvises. The primary outcome was the incidence of LC after surgery in symptomatic and asymptomatic patients. Imaging (ultrasound, computed tomography and magnetic resonance) was performed to detect LC at 3, 6 and 12 months after surgery.