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

January 28, 2011 updated by: University of Milano Bicocca
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Monza, Italy, 20052
        • San Gerardo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vessel sealing
axilla dissection using this device
Procedure: bipolar vessel sealing
Active Comparator: control
standard surgical technique
Procedure: control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
reduction of lymphorrhea rate
Time Frame: forth postoperative day
forth postoperative day

Secondary Outcome Measures

Outcome Measure
Time Frame
reduction of lymph output from the axillary drain
Time Frame: forth postoperative days
forth postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Investigators

  • Study Director: angelo nespoli, md, Milano-Bicocca University
  • Principal Investigator: luca gianotti, md, Milano-Bicocca University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

January 19, 2011

First Submitted That Met QC Criteria

January 28, 2011

First Posted (Estimate)

January 31, 2011

Study Record Updates

Last Update Posted (Estimate)

January 31, 2011

Last Update Submitted That Met QC Criteria

January 28, 2011

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ligasure
  • ligamonza

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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