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

This study has been completed.
Information provided by (Responsible Party):
Institut Claudius Regaud Identifier:
First received: September 22, 2005
Last updated: September 11, 2014
Last verified: June 2013
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.

Condition Intervention Phase
Vulvar Neoplasms
Skin Neoplasms
Device: ultracision
Device: classical lymphadenectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage.

Resource links provided by NLM:

Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • To evaluate the decrease of post-operative morbidity. [ Time Frame: 2012 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 73
Study Start Date: November 2005
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Classical surgical Inguinal curage
Classical Inguinal curage
Device: classical lymphadenectomy
classical lymphadenectomy
Experimental: Ultracision surgical Inguinal curage Device: ultracision
Surgery by Ultracision


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00224744

Institut Paoli-Calmettes
Marseille, France
Institut Claudius Regaud
Toulouse, France
Sponsors and Collaborators
Institut Claudius Regaud
Principal Investigator: Denis Querleu, Pr Institut Claudius Regaud
  More Information

Responsible Party: Institut Claudius Regaud Identifier: NCT00224744     History of Changes
Other Study ID Numbers: 05 DIVE 03
Study First Received: September 22, 2005
Last Updated: September 11, 2014

Keywords provided by Institut Claudius Regaud:
Vulvar Neoplasms
Skin Neoplasms

Additional relevant MeSH terms:
Skin Neoplasms
Vulvar Neoplasms
Neoplasms by Site
Skin Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Vulvar Diseases
Genital Diseases, Female processed this record on May 24, 2017