Breast Cancer Clinical Trial
Official title:
AND Precise! : Axillary Lymph Node Dissection and No Drain With the PRECISE Instrument
This study aims at providing first evidence that axillary clearance by using an operation technique including the precise LigaSure instrument and closure of dead space of the axilla will result in an operation were a drain is not necessary and the need for seroma evacuation after surgery is very limited.
Axillary clearance in breast cancer is usually performed by using a drain to prevent seroma
formation and to support obliteration of the dead space in the axillary carry out. The
hypothesis made in this protocol is that axillary clearance by using an operation technique
including the use of the precise LigaSure instrument and closure of dead space can be done
without using a postoperative drain.
The AND PRECISE PROTOCOL aims at providing first evidence that axillary clearance by using
an operation technique including the precise LigaSure instrument and closure of dead space
of the axilla will result in an operation were a drain is not necessary and the need for
seroma evacuation after surgery is very limited Patients undergoing axillary clearance
necessary for achieving reasonable control in invasive breast cancer and participating in
the AND PRECISE protocol will undergo the operation by using a technique including the use
of the precise LigaSure instrument and closure of dead space. Postoperatively, the numbers
of seroma punctions and the amount of seroma will be recorded prospectively. Patients will
be asked to record on a daily basis their experience of pain by a visual analog scale of
pain.
The main study parameter is the percent of cases which successfully did not need seroma
punctions after the intervention.
Potential disadvantages for the patient are risk for more seroma formation and discomfort.
Patients will be asked to record on a daily basis their experience of pain by a visual
analog scale of pain.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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