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Clinical Trials/NCT01286337
NCT01286337CompletedPhase 3

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

University of Milano Bicocca2 sites in 1 country116 target enrollmentStarted: April 2009Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
116
Locations
2
Primary Endpoint
reduction of lymphorrhea rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

reduction of lymphorrhea rate

Time Frame: forth postoperative day

Secondary Outcomes

  • reduction of lymph output from the axillary drain(forth postoperative days)

Investigators

Sponsor Class
Other

Study Sites (2)

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