Efficacy of a Fibrin Sealant for the Prevention of Lymphocele After Lymphadenectomy

Summary

Objective: Lymphocele (LC) is a potential complication of lymph node removal. The objective of this study was to assess the efficacy of the Tissucol Duo® (Baxter AG Industriestrasse 67 A-1221 Vienna, Austria) fibrin sealant in decreasing the incidence of LC after pelvic laparoscopic lymph node dissection using harmonic shears. Material and Methods: This prospective double blind randomised study was conducted between February 2012 and June 2016 in Donostia University Hospital (Spain). Overall, 74 patients diagnosed with gynaecological cancer gave written informed consent and were included in the study. After bilateral pelvic lymphadenectomy, the fibrin sealant was used following manufacturer's instructions in one hemipelvis but not the other. Overall, the product was applied in 41 (55.4%) left and 33 (44.6%) right hemipelvises. The primary objective of the study was to determine 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.

Timeline

Start

2012-02-01

Primary completion

2016-06-01

Completion

2016-06-01

Drugs

Indications