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NCT Number: NCT03248310

A Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management

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.

Recruiting

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Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, United States

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality of Life Assessments

Behavioral

Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.

Primary outcomes

  1. Quality of Life

    Time frame: up to 40 months

    Questionnaire to assess quality of life changes

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Barrio, MD

CONTACT

646-888-5118

Babak Mahrara, MD

CONTACT

[email protected]

646-608-8085

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

A Prospective Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2017
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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