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

This study has been completed.
Sponsor:
Information provided by:
University of Milano Bicocca
ClinicalTrials.gov Identifier:
NCT01286337
First received: January 19, 2011
Last updated: January 28, 2011
Last verified: August 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reduction of lymph output from the axillary drain [ Time Frame: forth postoperative days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Milano Bicocca

Additional 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
Study First Received: January 19, 2011
Last Updated: January 28, 2011
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013