Clinical trial · Interventional
Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage
Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage.
NCT00224744CI-TRIAL-00015605completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Neoplasms | Skin Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Vulvar Neoplasms | Vulvar Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| classical lymphadenectomy | Device | — | UNRESOLVED |
| ultracision | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Classical surgical Inguinal curage
- description
- Classical Inguinal curage
- interventionNames
- Device: classical lymphadenectomy
- type
- EXPERIMENTAL
- label
- Ultracision surgical Inguinal curage
- interventionNames
- Device: ultracision
Primary outcomes (1)
- measure
- To evaluate the decrease of post-operative morbidity.
- timeFrame
- 2012
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.