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

NCT ID: NCT03248310

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-09

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphedema

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Quality of Life Assessments

Intervention Type BEHAVIORAL

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

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.

Quality of Life Assessments

Intervention Type BEHAVIORAL

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

Interventions

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Quality of Life Assessments

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Babak Mahrara, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Babak Mahrara, MD

Role: CONTACT

646-608-8085

Andrea Barrio, MD

Role: CONTACT

646-888-5118

Facility Contacts

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Babak Mahrara, MD

Role: primary

646-608-8085

Andrea Barrio, MD

Role: backup

646-888-5118

Babak Mahrara, MD

Role: primary

646-608-8085

Andrea Barrio, MD

Role: backup

646-888-5118

Babak Mahrara, PhD

Role: primary

646-608-8085

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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17-377

Identifier Type: -

Identifier Source: org_study_id

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