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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01286337
First Posted: January 31, 2011
Last Update Posted: January 31, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Milano Bicocca
  Purpose
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: None (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286337


Locations
Italy
San Gerardo Hospital
Monza, Italy, 20052
Sponsors and Collaborators
University of Milano Bicocca
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gianotti Luca, Milano-Bicocca university
ClinicalTrials.gov Identifier: NCT01286337     History of Changes
Other Study ID Numbers: ligasure
ligamonza
First Submitted: January 19, 2011
First Posted: January 31, 2011
Last Update Posted: January 31, 2011
Last Verified: August 2010

Keywords provided by University of Milano Bicocca:
axilla
surgery
technique
bipolar vessel sealing

Additional relevant MeSH terms:
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs