Status:
COMPLETED
Application of Tachosil During Lymphadenectomy
Lead Sponsor:
Medical University of Lublin
Collaborating Sponsors:
Takeda
Conditions:
Lymphocele
Endometrial Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE4
Brief Summary
The prevention of lymphoceles was assessed using collagen patch coated with the human coagulation factors (TachoSil, Nycomed International Management GmbH, Zurich, Switzerland; NCT Number ICMJE NCT011...
Detailed Description
The study was approved by the Bioethics Committee of the Medical University of Lublin, Lublin, Poland (KE-0254/276/2013). The study population consisted of 50 women undergoing pelvic lymphadenectomy f...
Eligibility Criteria
Inclusion
- cervical cancer (FIGO IA1, IA2, IB1, IB2)
- endometrial cancer (FIGO IA, IB, II)
- age between 18 and 70 years
- signed a written informed consent
Exclusion
- lymph edema
- disease of the lymphatic system
- a known disease of the immune system
Key Trial Info
Start Date :
November 29 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03752606
Start Date
November 29 2013
End Date
December 31 2017
Last Update
November 26 2018
Active Locations (1)
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1
IInd Department of Gynecology
Lublin, Poland, 20-954