CompletedPhase 3

Tachosil for the Prevention of Symptomatic Lymph Cysts

Austria, Germany220 participantsStarted 2011-11

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

symptomatic lymph cysts

Timeframe: 4 weeks

Trial details

NCT IDNCT01470677

SponsorRuhr University of Bochum

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-01

View on ClinicalTrials.gov More Endometrial Cancer trials