Status:
COMPLETED
Tachosil for the Prevention of Symptomatic Lymph Cysts
Lead Sponsor:
Ruhr University of Bochum
Conditions:
Endometrial Cancer
Cervical Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief 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 a...
Detailed Description
1\. Background Women with gynecologic malignancies such as cervical and endometrial cancer routinely undergo pelvic lymphadenectomy based on tumor characteristics assessed prior to or during surgery. ...
Eligibility Criteria
Inclusion
- Women undergoing open or laparoscopic surgery for cervical or endometrial cancer
- Age between 18 and 70 yrs
- Informed consent
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01470677
Start Date
November 1 2011
End Date
January 1 2016
Last Update
July 8 2022
Active Locations (2)
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1
Medical University of Vienna
Vienna, Austria, A-1090
2
Ruhr University Bochum
Bochum, Germany, D-44625