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Axillary Lymphadenectomy. A Randomized Trial Comparing Bipolar Vessel Sealing To Conventional Technique

Axillary Lymphadenectomy. A Randomized Trial Comparing Bipolar Vessel Sealing To Conventional Technique

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01286337
Enrollment
116
Registered
2011-01-31
Start date
2009-04-30
Completion date
2011-01-31
Last updated
2011-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axilla Node Dissection

Keywords

axilla, surgery, technique, bipolar vessel sealing

Brief summary

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

Interventions

PROCEDUREbipolar vessel sealing
PROCEDUREcontrol

Sponsors

University of Milano Bicocca
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
reduction of lymphorrhea rateforth postoperative day

Secondary

MeasureTime frame
reduction of lymph output from the axillary drainforth postoperative days

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026