A Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
Overview
This study is being done to see the long-term results for patients who choose to have surgery for lymphedema (with the vascularized lymph node transfer), compared to patients who choose not to have surgery.
Full Title of Study: “A Prospective Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: August 2024
Interventions
- Behavioral: Quality of Life Assessments
- Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.
Arms, Groups and Cohorts
- vascularized lymph node transfer (VLNT)
- This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period.
- non-surgical treatment
- This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period.
Clinical Trial Outcome Measures
Primary Measures
- Quality of Life
- Time Frame: up to 40 months
- Questionnaire to assess quality of life changes
Participating in This Clinical Trial
Inclusion Criteria
- Patients aged 18-80 years – Primary and secondary lymphedema of the upper or lower extremity – International Society of Lymphology (ISL) Stage 1, 2, or 3 lymphedema – Proficiency in English language Exclusion Criteria:
- Patients with clotting disorders, venous insufficiency, end-stage lymphedema unless they are on the non-surgical arm. – Additionally, if the patient refuses to complete questionnaires, the patient will be excluded from the study and replaced at the discretion of the principal or co-principal investigator.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Investigator Details
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Babak Mahrara, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center
- Overall Contact(s)
- Babak Mahrara, MD, 646-608-8085, mehrarab@MSKCC.ORG
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