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

This study has been completed.
Information provided by:
University of Milano Bicocca Identifier:
First received: January 19, 2011
Last updated: January 28, 2011
Last verified: August 2010
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

Condition Intervention Phase
Axilla Node Dissection
Procedure: bipolar vessel sealing
Procedure: control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Axillary Lymphadenectomy. A Randomized Trial Comparing Bipolar Vessel Sealing To Conventional Technique

Further study details as provided by University of Milano Bicocca:

Primary Outcome Measures:
  • reduction of lymphorrhea rate [ Time Frame: forth postoperative day ]

Secondary Outcome Measures:
  • reduction of lymph output from the axillary drain [ Time Frame: forth postoperative days ]

Enrollment: 116
Study Start Date: April 2009
Study Completion Date: January 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vessel sealing
axilla dissection using this device
Procedure: bipolar vessel sealing
Active Comparator: control
standard surgical technique
Procedure: control


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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
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Please refer to this study by its identifier: NCT01286337

San Gerardo Hospital
Monza, Italy, 20052
Sponsors and Collaborators
University of Milano Bicocca
Study Director: angelo nespoli, md milano-bicocca university
Principal Investigator: luca gianotti, md milano-bicocca university
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gianotti Luca, Milano-Bicocca university Identifier: NCT01286337     History of Changes
Other Study ID Numbers: ligasure
Study First Received: January 19, 2011
Last Updated: January 28, 2011

Keywords provided by University of Milano Bicocca:
bipolar vessel sealing

Additional relevant MeSH terms:
Glucuronyl glucosamine glycan sulfate
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on April 26, 2017