A Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
A Prospective Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
1 other identifier
observational
600
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 9, 2017
CompletedFirst Submitted
Initial submission to the registry
August 10, 2017
CompletedFirst Posted
Study publicly available on registry
August 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
September 22, 2025
September 1, 2025
9 years
August 10, 2017
September 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life
Questionnaire to assess quality of life changes
up to 40 months
Study Arms (2)
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.
Interventions
Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.
Eligibility Criteria
Patients who present for consultation of their lymphedema and who meet eligibility criteria will be offered the option of enrolling in this study at the time of their initial consultation.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Babak Mahrara, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2017
First Posted
August 14, 2017
Study Start
August 9, 2017
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
September 22, 2025
Record last verified: 2025-09