This phase I trial studies the safety of a less invasive type of surgery, minimally invasive lymph node dissection, in treating patients with melanoma that has spread to the lymph nodes. Lymph node dissection is a surgical procedure in which the lymph nodes are removed to prevent cancer from growing there or to determine the stage of the cancer. A less invasive lymph node dissection procedure may reduce the risk of complications, reduce healthcare costs, and improve the quality of life of patients. Giving doctors training to teach them how to perform the surgery correctly may help them perform it better.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01500304.
PRIMARY OBJECTIVES:
I. To evaluate the safety of minimally invasive inguinal lymph node dissection in a phase I multi-institutional feasibility trial.
II. To characterize the learning curve of minimally invasive inguinal lymph node dissection in the clinical setting.
III. To assess if pre-course measures of basic laparoscopic technical skills correlate with post-course minimally invasive superficial groin dissection performance in a clinical setting, including operative oncologic standards and safety metrics.
OUTLINE:
Surgeons participate in an educational training program and learn how to perform a minimally invasive lymph node dissection (MILND). Patients then undergo MILND.
After completion of study treatment, patients are followed up at 30 and 90 days.
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorJames Ward Jakub
