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

NCT ID: NCT01286337

Last Updated: 2011-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Axilla Node Dissection

Keywords

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axilla surgery technique bipolar vessel sealing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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vessel sealing

axilla dissection using this device

Group Type EXPERIMENTAL

bipolar vessel sealing

Intervention Type PROCEDURE

control

standard surgical technique

Group Type ACTIVE_COMPARATOR

control

Intervention Type PROCEDURE

Interventions

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bipolar vessel sealing

Intervention Type PROCEDURE

control

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Milano Bicocca

OTHER

Sponsor Role lead

Responsible Party

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Milano-Bicocca university

Principal Investigators

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angelo nespoli, md

Role: STUDY_DIRECTOR

milano-bicocca university

luca gianotti, md

Role: PRINCIPAL_INVESTIGATOR

milano-bicocca university

Locations

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San Gerardo Hospital

Monza, , Italy

Site Status

Countries

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Italy

References

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Nespoli L, Antolini L, Stucchi C, Nespoli A, Valsecchi MG, Gianotti L. Axillary lymphadenectomy for breast cancer. A randomized controlled trial comparing a bipolar vessel sealing system to the conventional technique. Breast. 2012 Dec;21(6):739-45. doi: 10.1016/j.breast.2012.08.003. Epub 2012 Sep 7.

Reference Type DERIVED
PMID: 22959311 (View on PubMed)

Other Identifiers

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ligamonza

Identifier Type: -

Identifier Source: secondary_id

ligasure

Identifier Type: -

Identifier Source: org_study_id