NCT01286337

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 31, 2011

Completed
Last Updated

January 31, 2011

Status Verified

August 1, 2010

Enrollment Period

11 months

First QC Date

January 19, 2011

Last Update Submit

January 28, 2011

Conditions

Axilla Node Dissection

Keywords

axillasurgerytechniquebipolar vessel sealing

Outcome Measures

Primary Outcomes (1)

  • reduction of lymphorrhea rate

    forth postoperative day

Secondary Outcomes (1)

  • reduction of lymph output from the axillary drain

    forth postoperative days

Study Arms (2)

vessel sealing

EXPERIMENTAL

axilla dissection using this device

Procedure: bipolar vessel sealing

control

ACTIVE COMPARATOR

standard surgical technique

Procedure: control

Interventions

bipolar vessel sealingPROCEDURE
vessel sealing
controlPROCEDURE
control

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with documented breast cancer (by histology or cytology) and candidate to elective axillary lymphadenectomy

You may not qualify if:

  • Age less than 18 years
  • Denied written informed content
  • Previous axillary operations (except for sentinel node biopsy)
  • Preoperative radio-chemotherapy
  • Scheduled reconstructive breast operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Gerardo Hospital

Monza, 20052, Italy

Location

Related Publications (1)

  • 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.

    PMID: 22959311DERIVED

Study Officials

  • angelo nespoli, md

    milano-bicocca university

    STUDY DIRECTOR

  • luca gianotti, md

    milano-bicocca university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2011

First Posted

January 31, 2011

Study Start

April 1, 2009

Primary Completion

March 1, 2010

Study Completion

January 1, 2011

Last Updated

January 31, 2011

Record last verified: 2010-08

Locations

IT(1)