Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage

Institut Claudius Regaud73 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vulvar Neoplasms Skin Neoplasms

Interventions

ultracisionDEVICE

Surgery by Ultracision

classical lymphadenectomyDEVICE

classical lymphadenectomy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Institut Paoli-Calmettes

Marseille, France

Institut Claudius Regaud

Toulouse, France

Outcomes

Primary Outcomes

To evaluate the decrease of post-operative morbidity.

Time frame: 2012

Secondary Outcomes

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.

Time frame: 2012

Data from ClinicalTrials.gov

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