Skin Neoplasms Clinical Trial
Official title:
Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage.
The purpose of this study is to evaluate the decrease of post-operative morbidity in inguinal lymphadenectomies realised for vulvar tumors and inferior limb skin tumors by use of Ultracision with regard to classical operative techniques.
Status | Completed |
Enrollment | 73 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Vulvar neoplasm, inferior limb's skin malignant tumours, with an inguinal curage indication. - Age = 18 years - Hematological functions : leucocytes > 1500/mm3, hemoglobin > 8 g/dl, blood platelets > 150000/mm3. - Well informed written consent signed by the patient - Negative pregnancy test for female patient of child-bearing potential. Exclusion Criteria: - Preliminary surgery of inguinal cavity (sentinel lymph node removal accepted) - Massive lymph node invasion with femoro-vessels attack - Inclusion in another study (excepted study turned to inguinal lymph node) - Pregnant or nursing women - Patient under guardianship or trusteeship |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Institut Paoli-Calmettes | Marseille | |
France | Institut Claudius Regaud | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Institut Claudius Regaud |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the decrease of post-operative morbidity. | 2012 | No | |
Secondary | To study differences between the two techniques according to : operative duration ; operative difficulties ; quantity of drainage ; hospitalization's duration ; necessity of local care ; number of consultations ; medical and economical assessment. | 2012 | No |
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