Immediate Lymphatic Reconstruction After Lymphadenectomy in Melanoma Patients: a Parallel Cohort Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lymphovenous bypass (LVB).
- Who it may be relevant to
- Registry conditions: Lymphatic Reconstruction, Lymphadenectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure Lymphovenous bypass (LVB)
At the time of axillary lymph node dissection (ALND) or inguinal lymph node dissection (ILND) in the melanoma patient population.
Primary outcome measures
- Safety and adverse events [Time frame: Through study completion; an average of 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT06887205 · 2024-1357 · NCI-2025-01923