This pilot study assesses the performance of a robot-assisted microsurgery. Lympho-venular anastomosis(LVA) is the most difficult procedure in microsurgery at this moment. This LVA technique is applied to treat for example breast cancer related…
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameter is LVA anastomosis technique and the quality of the
anastomosis.
Secondary outcome
Secondary outcome measures include duration of surgery, technical errors during
surgery & complications peri-operatively, surgeon*s satisfaction with the LVA
procedure, surgeon*s learning curve with the procedure in practise, the
patients* convenience during surgery, arm volume over time and patient*s
symptom development over time.
Background summary
Microsurgery facilitates procedures such as transplantation of tissue as well
as lymph oedema treatment. Currently the surgeon*s hands are the limiting
factor in microsurgical performance. Robot-assistance increases the movement
precision and might therefore be of great importance for the advancement of
microsurgery in the world.
Study objective
This pilot study assesses the performance of a robot-assisted microsurgery.
Lympho-venular anastomosis(LVA) is the most difficult procedure in microsurgery
at this moment. This LVA technique is applied to treat for example breast
cancer related lymph oedema. Therefore, this LVA procedure is compared using a
manual expert and the same expert applying robot assisted LVA.
Study design
A prospective pilot study in Maastircht University Medical Center assesses
twenty patients to undergo either robot assisted (n=30) or manual LVA (n=30) to
treat the BRCLA. Primary outcome parameter is LVA anastomosis technique.
Secondary outcome measures include duration of surgery, technical errors during
surgery & complications peri-operatively, surgeon*s satisfaction with the LVA
procedure, the patients* convenience during surgery, arm volume over time and
patient*s symptom development over time.
Intervention
LVA is a minimally invasive procedure, which can be performed under local
anaesthesia. The indocyanine green (ICG) is injected into the second and fourth
finger webspace of the lymphedematous limb. Next, ICG lymphangiography is
performed. Using the photographs as a guide and the ICG angiography, the
injection sites fluorescent stains are identified. The patient*s limb is then
prepared for surgery.
Before making the incision, a mix of lidocaine and epinephrine is injected at
the site of incision to achieve local anaesthesia and optimal haemostasis.
Based on the ICG lymphangiography mapping incisions of 1.5 to 2 cm are made at
the predetermined sites. Lymphatic vessels are identified.
When a viable lymphatic vessel is identified it is end-toend anastomosed to a
similarly sized adjacent recipient venule in the subdermal plane.
Generally 1 to 3 anastomoses are made in a lymphedematous arm. The surgery
takes approximately two hours.
The robot assists the surgery implying that the movements of the surgeon are
delayed. The same instruments are used and surgery steps are identical to the
manual technique.
Study burden and risks
The robot holds the microsurgical instruments and is extensively tested in the
laboratory and on animals. It has not shown any negative side effect compared
to the experienced manual LVA techniques.
P Debeyelaan 25
Maastricht 6229 HX
NL
P Debeyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Female gender
- Age 18 years or older
- Treated for primary early stage breast cancer
- Early stage lymphedema of the arm (stage 1 or 2 on ISL classification)
- ELV >=10%
- Suffering unilateral disease and treatment
Exclusion criteria
- Male gender
- Stage 3 lymphedema of the arm
- Recurrent breast cancer
- Distant breast cancer metastases
- Current substance abuse
- History of marcaine or indocyanine green allergy
- Non-viable lymphatic system as determined by near infrared imaging
- Previous LVA in the arm with lymphedema (<10 years)
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
In other registers
Register | ID |
---|---|
CCMO | NL60199.068.16 |
Other | NL6291 |