Back to resultsProspective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage
Primary Purpose
Vulvar Neoplasms, Skin Neoplasms
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
ultracision
classical lymphadenectomy
Sponsored by
About this trial
This is an interventional treatment trial for Vulvar Neoplasms focused on measuring Vulvar Neoplasms, Skin Neoplasms, Ultracision, Lymphadenectomy
Eligibility 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
Sites / Locations
- Institut Paoli-Calmettes
- Institut Claudius Regaud
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Classical surgical Inguinal curage
Ultracision surgical Inguinal curage
Arm Description
Classical Inguinal curage
Outcomes
Primary Outcome Measures
To evaluate the decrease of post-operative morbidity.
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.
Full Information
NCT ID
NCT00224744
First Posted
September 22, 2005
Last Updated
September 11, 2014
Sponsor
Institut Claudius Regaud
1. Study Identification
Unique Protocol Identification Number
NCT00224744
Brief Title
Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage
Official Title
Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Neoplasms, Skin Neoplasms
Keywords
Vulvar Neoplasms, Skin Neoplasms, Ultracision, Lymphadenectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Classical surgical Inguinal curage
Arm Type
Active Comparator
Arm Description
Classical Inguinal curage
Arm Title
Ultracision surgical Inguinal curage
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ultracision
Intervention Description
Surgery by Ultracision
Intervention Type
Device
Intervention Name(s)
classical lymphadenectomy
Intervention Description
classical lymphadenectomy
Primary Outcome Measure Information:
Title
To evaluate the decrease of post-operative morbidity.
Time Frame
2012
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Querleu, Pr
Organizational Affiliation
Institut Claudius Regaud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Paoli-Calmettes
City
Marseille
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
Country
France
12. IPD Sharing Statement
Learn more about this trial
Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage
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