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OSU-12055: Safety and Feasibility of Minimally Invasive Inguinal Lymph Node Dissection (SAFE-MILND)

HYPOTHESIS: That minimally invasive groin dissection is a safe procedure; 2. That the learning curve for minimally invasive inguinal lymph node dissection for those with inguinal lymph node dissection experience will be steep; 3. That 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.

RATIONALE: Regional lymph nodes (LNs) are the most frequent site of melanoma spread. The presence of tumor cells in LNs, if left untreated, can result in disease progression and an increased risk of death. Patients with melanoma that is metastatic to the inguinal lymph nodes may require a complete lymph node dissection.

The standard open inguinal LN dissection involves a long incision that crosses the inguinal crease. The procedure is associated with a high incidence—up to 50 percent in some series—of complications such as wound infection, wound dehiscence, seroma formation, venous thrombotic events and lymphedema. These can result in extended hospitalization, reduced quality of life, delayed return to normal activities and increased healthcare costs. Interventions that attempt to minimize these problems have been unsuccessful. Lymphedema remains a chronic, incurable condition.

This phase I multicenter trial evaluates the benefits and safety of minimally invasive lymph node dissection as a novel approach to inguinal LN staging and treatment. The procedure is performed through three small incisions in the thigh, utilizing a camera and special instruments.

Post-operative evaluation for adverse events will occur after 30 and 90 days. Lymphedema will be assessed using leg-volume measurements at baseline and during postoperative follow-up. Finally, the study assesses the efficacy of a specific didactic and hands-on training program designed to teach surgeons to perform this new procedure.

AT A GLANCE
OSU-11055 (ClinicalTrials.gov identifier: NCT01500304)

PI: ALICIA TERANDO, MD

Phone: 614-293-8890

Email: alicia.terando@osumc.edu

Eligibility: Age 18 years or older; malignant melanoma present in an inguinal node basin requiring superficial inguinal lymph node dissection; surgical plan for superficial inguinal dissection; clinical or radiographic evidence of superficial inguinal lymph node disease; able to tolerate general anesthesia; female patients of childbearing age must have a negative pregnancy test, be surgically sterile or post-menopausal for a year or more.

 
16-Jan-14
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