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

Institut Claudius Regaud

Status and phase: Completed; Phase 3

Conditions: Vulvar Neoplasms; Skin Neoplasms

Treatments: Device: classical lymphadenectomy; Device: ultracision

Study type: Interventional

Funder types: Other

Identifiers

NCT00224744

05 DIVE 03

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Classical surgical Inguinal curage

Active Comparator group

Description:

Classical Inguinal curage

Treatment:

Device: classical lymphadenectomy

Ultracision surgical Inguinal curage

Experimental group

Treatment:

Device: ultracision