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

Phase 3

Completed

• Conditions: Axilla Node Dissection
• Interventions: Procedure: bipolar vessel sealing; Procedure: control

• Registration Number: NCT01286337
• Lead Sponsor: University of Milano Bicocca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2010-03
• Status Verified: 2010-08
• Study Completion: 2011-01
• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-01-28
• Last Update Submitted: 2011-01-28
• Study First Posted: 2011-01-31
• Last Update Posted: 2011-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vessel sealing	bipolar vessel sealing	axilla dissection using this device
control	control	standard surgical technique

Primary Outcome Measures

Name	Time	Method
reduction of lymphorrhea rate	forth postoperative day

Secondary Outcome Measures

Name	Time	Method
reduction of lymph output from the axillary drain	forth postoperative days

Trial Locations

Locations (1)

San Gerardo Hospital; 🇮🇹 Monza, Italy