Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT06887205

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELymphovenous bypass (LVB)At the time of axillary lymph node dissection (ALND) or inguinal lymph node dissection (ILND) in the melanoma patient population.

Timeline

Start date
2026-09-06
Primary completion
2028-09-01
Completion
2028-09-01
First posted
2025-03-20
Last updated
2025-10-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06887205. Inclusion in this directory is not an endorsement.