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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37683
Enrollment
20
Registered
2012-05-01
Start date
2012-02-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

axillary clearance Breast cancer

Interventions

The intervention is axillary clearance by using an operation technique including the precise LigaSure instrument and closure of dead space of the axilla.

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The main study parameter is the percent of cases which successfully did not need seroma punctions after the intervention.

Secondary

MeasureTime frame
nvt

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)