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…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the percent of cases which successfully did not
need seroma punctions after the intervention.
Secondary outcome
nvt
Background summary
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.
Study objective
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
Study design
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.
Intervention
The intervention is axillary clearance by using an operation technique
including the precise LigaSure instrument and closure of dead space of the
axilla.
Study burden and risks
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.
Benefits and risks assessment, group relatedness
Omission of the use of an axillary drain has a number of potential advantages:
o Less in hospital stay
o Less infection
o More convenient for the patient
o Less visits to the clinic
o Less procedures for surgeon and the nurse
o Less costs
Plesmanlaan 121
1066 CX Amsterdam
NL
Plesmanlaan 121
1066 CX Amsterdam
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38865.031.12 |