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CompletedNCT01286337Updated Jan 31, 2011

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

A Phase 3 interventional study of bipolar vessel sealing and control in Axilla Node Dissection, sponsored by University of Milano Bicocca. Completed at 1 site in Italy. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-01-31.

Sponsored by University of Milano Bicocca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Axilla Node Dissection

Keywords

  • axilla
  • surgery
  • technique
  • bipolar vessel sealing
03

In context

Lead sponsor

University of Milano Bicocca is the lead sponsor of 124 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
116 participants (actual)

Study arms

  • Experimental
    vessel sealing

    axilla dissection using this device

    Procedure: bipolar vessel sealing

  • Active comparator
    control

    standard surgical technique

    Procedure: control

Interventions

  • Procedurebipolar vessel sealing
  • Procedurecontrol
06

What researchers measure

Primary outcomes

  1. reduction of lymphorrhea rate

    Time frame: forth postoperative day

Secondary outcomes

  1. reduction of lymph output from the axillary drain

    Time frame: forth postoperative days

07

Study locations

1 site
  • San Gerardo Hospital
    Monza, 20052, Italy
08

References and documents

Publications

  • 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. PubMed 22959311 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01286337
Lead sponsor
University of Milano Bicocca
First posted
Jan 31, 2011
Start date
Apr 2009
Primary completion
Mar 2010
Completion
Jan 2011
Last update
Jan 31, 2011

Study contacts

angelo nespoli, md
study director · milano-bicocca university
luca gianotti, md
principal investigator · milano-bicocca university

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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