Skin Neoplasms, Vulvar Neoplasms
Conditions
Keywords
Vulvar Neoplasms, Skin Neoplasms, Ultracision, Lymphadenectomy
Brief summary
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.
Interventions
DEVICEultracision
Surgery by Ultracision
DEVICEclassical lymphadenectomy
classical lymphadenectomy
Sponsors
Institut Claudius Regaud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the decrease of post-operative morbidity. | 2012 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed