Minimally Invasive Groin Dissection for Melanoma

Completed · Not applicable

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT01500304

Run by

Mayo Clinic

People needed

88

Starts

2012-06-01

Expected to finish

2015-12-01

Last updated by the study team

2018-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Malignant melanoma present in an inguinal nodal basin requiring superficial inguinal lymph node dissection.
• Plan for superficial inguinal dissection alone or combined superficial inguinal and deep pelvic node dissection is acceptable.
• Clinical or radiographic evidence of superficial inguinal lymph node disease or a prior positive single lymph node biopsy of the superficial inguinal basin as an indication for superficial inguinal lymph node disease is acceptable.
• Patients must be Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and be healthy enough to undergo a general anesthetic (no epidural or spinal anesthetics).
• Female patients of child bearing age must have a negative pregnancy test, be surgically sterile or post-menopausal greater than 1 year.
• Patients must be able to return to surgical facility for 30 and/or 90 day (+/- 20 days) for follow-up appointment.

You may not qualify if…

• Prior ipsilateral superficial inguinal lymph node dissection
• Invasion or ulceration of inguinal nodal disease into the overlying skin
• Prior radiation therapy to the same regional nodal basin.

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• John Wayne Cancer Institute — Santa Monica, California, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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