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

Phase 3

Completed

• Conditions: Vulvar Neoplasms; Skin Neoplasms
• Interventions: Device: ultracision; Device: classical lymphadenectomy

• Registration Number: NCT00224744
• Lead Sponsor: Institut Claudius Regaud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-22
• Study First Submitted QC: 2005-09-22
• Study First Posted: 2005-09-23
• Study Start: 2005-11
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-06
• Last Update Submitted: 2014-09-11
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultracision surgical Inguinal curage	ultracision	-
Classical surgical Inguinal curage	classical lymphadenectomy	Classical Inguinal curage

Primary Outcome Measures

Name	Time	Method
To evaluate the decrease of post-operative morbidity.	2012

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Institut Paoli-Calmettes; 🇫🇷 Marseille, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France