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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03248310

Enrollment

600

Registered

2017-08-14

Start date

2017-08-09

Completion date

2026-08-31

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema

Keywords

Quality of Life (QoL), 17-377

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.

Interventions

BEHAVIORALQuality of Life Assessments

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Quality of Life	up to 40 months	Questionnaire to assess quality of life changes

Countries

United States

Contacts

Primary ContactBabak Mahrara, MD

mehrarab@MSKCC.ORG646-608-8085

Backup ContactAndrea Barrio, MD

646-888-5118

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026