NCT03248310
Recruiting
Not Applicable
A Prospective Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
ConditionsLymphedema
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lymphedema
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 600
- Locations
- 3
- Primary Endpoint
- Quality of Life
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Quality of Life
Time Frame: up to 40 months
Questionnaire to assess quality of life changes
Study Sites (3)
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