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Not yet recruiting Not applicable NCT06887205

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

No applicable phase (e.g. observational)
Conditions: Lymphatic Reconstruction Lymphadenectomy

Sponsor: M.D. Anderson Cancer Center

trial.available_in: БГ
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.
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.
Who can participate
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
Interventions
Lymphovenous bypass (LVB)
PROCEDURE
Locations 1
United States (1)
MD Anderson Cancer Center
Houston , Texas
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
06.09.2026
Completion date
01.09.2028
Registry ID
NCT06887205
Source
clinicaltrials.gov
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