Axillary lymph node dissection without drain AND with the LigaSure Precise instrument (ANDPrecise)

Phase 2

• Conditions: axillary clearance; Breast cancer; 10006291

• Registration Number: NL-OMON37683
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Patients undergoing axillary clearance for proven lymph node metastases in order to achieve good control in invasive breast cancer.
o Indications for axillary clearance is tumor proven axillary lymph node metastasis
o Or tumor positive lymph nodes proven by ultrasound and fine needle aspiration cytology.
o For this pilot only patients undergoing breast conserving therapy are eligible.
o Axillary clearance can be performed after previous sentinel node procedure, at the same operation, and after neo-adjuvant chemo therapy, and as secondary procedure in case of axillary relapse after previous treatment for breast cancer.
o There is no age limit

Exclusion Criteria

o Patients undergoing a modified radical mastectomy including an axillary clearance.
o Preoperative pre existing seroma

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the percent of cases which successfully did not<br /><br>need seroma punctions after the intervention.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>nvt</p><br>