Recruiting NCT03248310
A Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
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: Quality of Life Assessments.
- Who it may be relevant to
- Registry conditions: Lymphedema. Basic parameters: 18 years — 80 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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Official title
A Prospective 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.
Interventions
- Behavioral Quality of Life Assessments
Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.
Primary outcome measures
- Quality of Life [Time frame: up to 40 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
United States · 3 centers
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
- Memorial Sloan Kettering Cancer Center — New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre
Identifiers
NCT: NCT03248310 · 17-377