Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2012-06-30
2015-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Minimally invasive surgery
Minimally invasive inguinal lymph node dissection is a 10-step technique to provide novel inguinal lymph node staging and treatment.
Minimally invasive inguinal lymph node dissection
Operative intervention will be a minimally invasive inguinal lymphadenectomy, which is a three trocar technique to the inguinal dissection, that respects the same anatomic boundaries as the conventional open procedure
Interventions
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Minimally invasive inguinal lymph node dissection
Operative intervention will be a minimally invasive inguinal lymphadenectomy, which is a three trocar technique to the inguinal dissection, that respects the same anatomic boundaries as the conventional open procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Invasion or ulceration of inguinal nodal disease into the overlying skin
* Prior radiation therapy to the same regional nodal basin.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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James W. Jakub
Breast and Melanoma Surgery Section Head
Principal Investigators
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James Jakub, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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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
Countries
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References
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Jakub JW, Reintgen DS, Shivers S, Pendas S. Regional node dissection for melanoma: techniques and indication. Surg Oncol Clin N Am. 2007 Jan;16(1):247-61. doi: 10.1016/j.soc.2006.10.012.
Abbott AM, Grotz TE, Rueth NM, Hernandez Irizarry RC, Tuttle TM, Jakub JW. Minimally invasive inguinal lymph node dissection (MILND) for melanoma: experience from two academic centers. Ann Surg Oncol. 2013 Jan;20(1):340-5. doi: 10.1245/s10434-012-2545-6. Epub 2012 Aug 9.
Jakub JW, Terando AM, Sarnaik A, Ariyan CE, Faries MB, Zani S Jr, Neuman HB, Wasif N, Farma JM, Averbook BJ, Bilimoria KY, Grotz TE, Allred JB, Suman VJ, Brady MS, Tyler D, Wayne JD, Nelson H. Safety and Feasibility of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma (SAFE-MILND): Report of a Prospective Multi-institutional Trial. Ann Surg. 2017 Jan;265(1):192-196. doi: 10.1097/SLA.0000000000001670.
Jakub JW, Terando AM, Sarnaik A, Ariyan CE, Faries MB, Zani S Jr, Neuman HB, Wasif N, Farma JM, Averbook BJ, Bilimoria KY, Allred JB, Suman VJ, Grotz TE, Zendejas B, Wayne JD, Tyler DS. Training High-Volume Melanoma Surgeons to Perform a Novel Minimally Invasive Inguinal Lymphadenectomy: Report of a Prospective Multi-Institutional Trial. J Am Coll Surg. 2016 Mar;222(3):253-60. doi: 10.1016/j.jamcollsurg.2015.11.010. Epub 2015 Nov 25.
Other Identifiers
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10-007790
Identifier Type: -
Identifier Source: org_study_id
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