Tachosil for the Prevention of Symptomatic Lymph Cysts
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
This is a randomized trial of 140 women with endometrial or cervical cancer undergoing
removal of lymph tissue (lymphadenectomy). The application of 4 tachosil fibrin patches to
the pelvic side wall after tissue removal is tested against no such intervention after tissue
removal. The primary endpoint is to evaluate the incidence of symptomatic pelvic lymphoceles
defined by CTCAE 4.03 grade >2 within 4 weeks after surgery in women undergoing open or
laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and without the
application of Tachosil® during surgery. The study's hypothesis is that the application of
tachosil fibrin patches will significantly reduce the rate of symptomatic lymph cysts.