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

University of Milano Bicocca

Status and phase: Completed; Phase 3

Conditions: Axilla Node Dissection

Treatments: Procedure: control; Procedure: bipolar vessel sealing

Study type: Interventional

Funder types: Other

Identifiers

NCT01286337

ligamonza

ligasure

Details and patient eligibility

About

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

Enrollment: 116 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

vessel sealing

Experimental group

Description:

axilla dissection using this device

Treatment:

Procedure: bipolar vessel sealing

control

Active Comparator group

Description:

standard surgical technique

Treatment:

Procedure: control