Robot-assisted surgery for treating lymphedema in breast cancer patients
Pilot Study on Robotic Assisted Microsurgical Lymphatico-venular Anastomosis
NA · Maastricht University Medical Center · NCT06532955
This study is testing if robot-assisted surgery for lymphedema can help women with breast cancer feel better compared to traditional surgery done by hand.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Maastricht University Medical Center (other) |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT06532955 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of robot-assisted microsurgery for lymphaticovenous anastomosis (LVA) in patients suffering from breast cancer-related lymphedema. It compares the outcomes of robot-assisted LVA with manual LVA performed by the same expert surgeon. The study aims to assess various parameters including surgery duration, technical errors, surgeon satisfaction, and patient symptoms over time. A total of 60 female patients with early-stage lymphedema will be enrolled at Maastricht University Medical Center.
Who should consider this trial
Good fit: Ideal candidates are female patients who have been treated for early-stage breast cancer and are experiencing stage 1 or 2 lymphedema of the arm.
Not a fit: Patients with advanced stage lymphedema (stage 3) or those currently undergoing breast cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes and recovery for patients with breast cancer-related lymphedema.
How similar studies have performed: While robot-assisted microsurgery is a growing field, this specific application for lymphedema treatment is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Male gender; * Stage 3 lymphedema of the arm; * Receiving current breast cancer treatment; * 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 (\<10 years) in the arm with lymphedema.
Where this trial is running
Maastricht, Limburg
- Maastricht University Medical Center+ — Maastricht, Limburg, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Shan Shan Qiu Shao, MSc, PhD — Maastricht University Medical Center
- Study coordinator: Alieske Kleeven, MSc
- Email: alieske.kleeven@mumc.nl
- Phone: +31(0)433877481
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm, Lymphedema of Upper Limb, Surgical, Lymphedema, Secondary, Lymphedema of Limb, Lymphedema, Breast Cancer