Lymphadenectomy, Lymphatic Reconstruction
Conditions
Brief summary
To learn if LBP can help to prevent lymphedema when it is performed at the time of surgery rather than after a patient has already developed the disease.
Detailed description
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.
Interventions
PROCEDURELymphovenous bypass (LVB)
At the time of axillary lymph node dissection (ALND) or inguinal lymph node dissection (ILND) in the melanoma patient population.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and adverse events | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events |
Countries
United States
Contacts
CONTACTAshleigh M Francis, MD
PRINCIPAL_INVESTIGATORAshleigh M Francis, MD
M.D. Anderson Cancer Center
Outcome results
None listed