Melanoma Clinical Trial
Official title:
Feasibility and Safety of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma
The purpose of this this study is to determine if a structured educational training program is successful in teaching surgeons a new operative technique. It will then be determined if this new operative technique is safe.
This study is a multi-center, Phase 1 clinical trial to determine the safety and feasibility
of minimally invasive inguinal lymph node dissection for patients with melanoma. Licensed
surgeons who have undergone special training, including a course at the Mayo Clinic Rochester
in minimally invasive lymph node dissection (MILND) will perform the new procedure at their
home institutions. The study will characterize the learning curve of MILND in the clinical
setting, and evaluate the safety of the new operative technique.
The hypotheses for this study are: 1) minimally invasive groin dissection is a safe
procedure. 2) a structured educational training program is a feasible and effective method to
train practicing surgeons in this novel procedure and 3) pre-course generic laparoscopic
technical skills correlate with minimally invasive superficial groin dissection performance
in a clinical setting, including operative oncologic standards and safety metrics.
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