Immediate Lymphatic Reconstruction After Lymphadenectomy in Melanoma Patients: a Parallel Cohort Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Safety and adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants greater than or equal to 18 years of age.
- •Participants willing to participate.
- •Participants able to complete informed consent.
- •Participants with a diagnosis of Melanoma undergoing ALND or ILND.
Exclusion Criteria
- •Participant staking anticoagulants within 7 days prior to surgery.
- •Participants that are known to be pregnant at the time of surgery.
- •Participants with BMI greater than 50.0
Arms & Interventions
Upper extremity group recieving ALND
Participants will be recruited pre-operatively by their treating physicians.
Intervention: Lymphovenous bypass (LVB) (Procedure)
Lower extremity group getting ILND
Participants will be recruited pre-operatively by their treating physicians.
Intervention: Lymphovenous bypass (LVB) (Procedure)
Outcomes
Primary Outcomes
Safety and adverse events
Time Frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events
Secondary Outcomes
No secondary outcomes reported