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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT00224744
First received: September 22, 2005
Last updated: September 11, 2014
Last verified: June 2013
  Purpose

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
Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT00224744     History of Changes
Other Study ID Numbers: 05 DIVE 03
Study First Received: September 22, 2005
Last Updated: September 11, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 30, 2014