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Immediate Lymphatic Reconstruction After Lymphadenectomy in Melanoma Patients: a Parallel Cohort Pilot Study

NCT06887205 · M.D. Anderson Cancer Center
In plain English

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About this study
To examine if performing lymphovenous bypass (LVB) at the time of axillary lymph node dissection (ALND) or inguinal lymph node dissection (ILND) in the melanoma participant population impacts the period prevalence of lymphedema occurrence one year from surgery. To assess wound complications rates occurring in first 30-days post operatively from the time of surgery. To estimate time to drain removal. To estimate the point prevalence of LE following surgery at 3 months, 6 months, and 1 year following surgery. To estimate the cumulative incidence associated with the first appearance of LE. To assess quality of life and survivorship, using Lymphedema Quality of Life (LYMQOL) questionnaire over the study follow-up domain.
Eligibility criteria
Inclusion Criteria: 1. Participants greater than or equal to 18 years of age. 2. Participants willing to participate. 3. Participants able to complete informed consent. 4. Participants with a diagnosis of Melanoma undergoing ALND or ILND. Exclusion Criteria: 1. Participant staking anticoagulants within 7 days prior to surgery. 2. Participants that are known to be pregnant at the time of surgery. 3. Participants with BMI greater than 50.0
Study design
Enrollment target: 20 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-06-10
Estimated completion: 2028-09-01
Last updated: 2026-06-18
Interventions
Procedure: Lymphovenous bypass (LVB)
Primary outcomes
  • Safety and adverse events (Through study completion; an average of 1 year)
Sponsor
M.D. Anderson Cancer Center · other
Contacts & investigators
ContactAshleigh M Francis, MD · contact · amfrancis@mdanderson.org · (713) 413-7451
InvestigatorAshleigh M Francis, MD · principal_investigator, M.D. Anderson Cancer Center
All locations (1)
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States