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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014