Pilot Study on Robotic Assisted Microsurgical Lymphatico-venular Anastomosis
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study assesses the performance of robot-assisted microsurgery. Lymphaticovenous anastomosis (LVA) is the most difficult procedure in microsurgery at this moment. The LVA technique is applied to treat for example breast cancer-related lymphedema (BCRL). Therefore, this LVA procedure is compared using a manual expert and the same expert applying robot-assisted LVA.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Female gender;
• Treated for primary early stage breast cancer;
• Early stage lymphedema of the arm (stage 1 or 2 on ISL classification);
• ELV \> 10%;
• Suffering from unilateral disease.
Locations
Other Locations
Netherlands
Maastricht University Medical Center+
RECRUITING
Maastricht
Contact Information
Primary
Alieske Kleeven, MSc
alieske.kleeven@mumc.nl
+31(0)433877481
Time Frame
Start Date: 2017-06-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 60
Treatments
Experimental: Lymphaticovenous anastomosis using Microsure Motion Stabilizer
Patients in this group undergo robot-assisted lymphaticovenous anastomosis at one or more locations on the affected arm. The procedure is performed under local anesthesia. Incisions are made at the sites where lymphatic vessels are obstructed, ensuring no harm to the viable part of the lymphatic system. The location(s) are determined prior to surgery using ICG lymphography. LVA(s) are made in the subdermal plane with the aid of a surgical microscope. Generally, 1 to 4 LVAs are made. The LVAs are madeusing a surgical microscope and the operation takes approximately 240 minutes.
Active_comparator: Lymphaticovenous anastomosis
Patients in this group undergo lymphaticovenous anastomosis at one or more locations on the affected arm. The procedure is performed under local anesthesia. Incisions are made at the sites where lymphatic vessels are obstructed, ensuring no harm to the viable part of the lymphatic system. The location(s) are determined prior to surgery using ICG lymphography. LVA(s) are made in the subdermal plane with the aid of a surgical microscope. Generally, 1 to 4 LVAs are made. The LVAs are madeusing a surgical microscope and the operation takes approximately 90 minutes.
Related Therapeutic Areas
Sponsors
Leads: Maastricht University Medical Center