Comparing quality of life in lymphedema patients after surgery versus non-surgical management
A Prospective Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
This study looks at whether surgery or non-surgical treatment helps people with lymphedema feel better in the long run.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 3 sites (Harrison, New York and 2 other locations) |
| Trial ID | NCT03248310 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the long-term quality of life outcomes for patients with lymphedema who undergo surgical treatment, specifically vascularized lymph node transfer, compared to those who opt for non-surgical management. Participants will be assessed for their quality of life over time, providing insights into the effectiveness of surgical intervention versus conservative treatment. The study includes patients aged 18-80 with varying stages of lymphedema and will exclude those with certain medical conditions or who cannot complete questionnaires.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with primary or secondary lymphedema of the upper or lower extremity at ISL stages 1, 2, or 3.
Not a fit: Patients with clotting disorders, venous insufficiency, or end-stage lymphedema may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the benefits of surgical treatment for lymphedema, potentially improving patient care and decision-making.
How similar studies have performed: While this study focuses on a specific surgical approach, similar studies have shown promising results in improving quality of life for lymphedema patients through surgical interventions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Harrison, New York and 2 other locations
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Babak Mahrara, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Babak Mahrara, MD
- Email: mehrarab@MSKCC.ORG
- Phone: 646-608-8085
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.