Axilla Node Dissection Clinical Trial
Official title:
Axillary Lymphadenectomy. A Randomized Trial Comparing Bipolar Vessel Sealing To Conventional Technique
| Verified date | August 2010 |
| Source | University of Milano Bicocca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ministry of Health |
| Study type | Interventional |
lymphorrehea remains the most frequent complication after axillary lymphadenectomy. we hyphothesize that the use of a bipolar vessel sealing may reduce the rate of lymph collection compared to the traditional surgical technique
| Status | Completed |
| Enrollment | 116 |
| Est. completion date | January 2011 |
| Est. primary completion date | March 2010 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Women with documented breast cancer (by histology or cytology) and candidate to elective axillary lymphadenectomy Exclusion Criteria: - Age less than 18 years - Denied written informed content - Previous axillary operations (except for sentinel node biopsy) - Preoperative radio-chemotherapy - Scheduled reconstructive breast operation |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | San Gerardo Hospital | Monza |
| Lead Sponsor | Collaborator |
|---|---|
| University of Milano Bicocca |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | reduction of lymphorrhea rate | forth postoperative day | No | |
| Secondary | reduction of lymph output from the axillary drain | forth postoperative days | No |