Tachosil for the Prevention of Symptomatic Lymph Cysts

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruhr University of Bochum

Criteria

Inclusion Criteria:

• Women undergoing open or laparoscopic surgery for cervical or endometrial cancer

• Age between 18 and 70 yrs

• Informed consent

Exclusion Criteria:

• Women with previously diagnosed lymph edema

• Known disease of the lymphatic system

• Immunocompromised women such as those with an immunosuppressive medication or a known disease of the immune system