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OpenTrials
Completed

NCT Number: NCT01286337

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

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

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Key information

Conditions

Axilla Node Dissection

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

San Gerardo Hospital

Monza, 20052, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bipolar vessel sealing

Procedure

Control

Procedure

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

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jan 31, 2011
Registry last updated
Jan 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.