Minimally Invasive Groin Dissection for Melanoma
- Conditions
- Melanoma
- Interventions
- Procedure: Minimally invasive inguinal lymph node dissection
- Registration Number
- NCT01500304
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Minimally invasive surgery Minimally invasive inguinal lymph node dissection Minimally invasive inguinal lymph node dissection is a 10-step technique to provide novel inguinal lymph node staging and treatment.
- Primary Outcome Measures
Name Time Method Proficiency score per surgery Approximately 90 days following surgical procedure The proficiency score is a function of the lymph nodes pathologically identified, the amount of blood transfused and the operative time. The range is 0 to 3, with higher proficiency in performing the procedure being 3.
- Secondary Outcome Measures
Name Time Method Morbidity and percentage of patients converted to open surgical procedure Approximately 90 days following surgical procedure Perioperative morbidity will be prospectively collected and reported.Percentage of participants that require conversion from MILND to open procedure (standard of care). Conversion to the open procedure is required if the operation is not progressing, an adequate oncologic procedure cannot be completed or if bleeding is encountered that cannot be safety controlled videoscopically.
Trial Locations
- Locations (11)
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
John Wayne Cancer Institute
🇺🇸Santa Monica, California, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States