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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00224744
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Vulvar Neoplasms Skin Neoplasms Device: ultracision Device: classical lymphadenectomy Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage.
Study Start Date : November 2005
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Classical surgical Inguinal curage
Classical Inguinal curage
Device: classical lymphadenectomy
classical lymphadenectomy
Experimental: Ultracision surgical Inguinal curage Device: ultracision
Surgery by Ultracision


Outcome Measures

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

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224744


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

Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT00224744     History of Changes
Other Study ID Numbers: 05 DIVE 03
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: June 2013

Keywords provided by Institut Claudius Regaud:
Vulvar Neoplasms
Skin Neoplasms
Ultracision
Lymphadenectomy

Additional relevant MeSH terms:
Neoplasms
Skin Neoplasms
Vulvar Neoplasms
Neoplasms by Site
Skin Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Vulvar Diseases
Genital Diseases, Female