A Collagen-Fibrin Patch (Tachosil®) for the Prevention of Symptomatic Lymphatic Cysts after Removal of Lymph Nodes in the Pelvis in Women with Gynecologic Cancer: a Randomized Clinical Trial
Phase 1
- Conditions
- endometrial cancer, cervical cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-003115-34-AT
- Lead Sponsor
- Medizinische Universität Wien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 140
Inclusion Criteria
-Women undergoing open or laparoscopic surgery for cervical or endometrial cancer
-Age between 18 and 70 yrs
-Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method