ClinicalTrials.gg
RecruitingNCT03248310Updated Sep 24, 2026

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

An observational study in Lymphedema, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

From the registry’s dates

  • Started Aug 2017; still recruiting 9 years 3 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
600
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lymphedema

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Keywords

  • Quality of Life (QoL)
  • 17-377
03

In context

Lymphedema

529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.

This study's planned enrollment of 600 is above the median of 103 across 145 observational studies indexed under Lymphedema.

Browse Lymphedema studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Behavioral: Quality of Life Assessments

  • 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.

    Behavioral: Quality of Life Assessments

Interventions

  • BehavioralQuality of Life Assessments

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

06

What researchers measure

Primary outcomes

  1. Quality of Life

    Questionnaire to assess quality of life changes

    Time frame: up to 40 months

07

Study locations

3 of 3 sites recruiting
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
    Harrison, New York 10604, United States
    Recruiting
    • Babak Mahrara, MD · Contact646-608-8085
    • Andrea Barrio, MD · Contact646-888-5118
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    Recruiting
    • Babak Mahrara, MD · Contact646-608-8085
    • Andrea Barrio, MD · Contact646-888-5118
  • Memorial Sloan Kettering Nassau (Limited Protocol Activites)
    Rockville Centre, New York 11553, United States
    Recruiting
    • Babak Mahrara, PhD · Contact646-608-8085
08

References and documents

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03248310
Responsible party
Sponsor
First posted
Aug 14, 2017
Start date
Aug 9, 2017
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Sep 24, 2026

Study contacts

Babak Mahrara, MD
Contact
mehrarab@MSKCC.ORG
646-608-8085
Andrea Barrio, MD
Contact
646-888-5118
Babak Mahrara, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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