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

Overview

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.

Full Title of Study: “A Prospective Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2024

Interventions

  • Behavioral: Quality of Life Assessments
    • Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.

Arms, 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Quality of Life
    • Time Frame: up to 40 months
    • Questionnaire to assess quality of life changes

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Babak Mahrara, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center
  • Overall Contact(s)
    • Babak Mahrara, MD, 646-608-8085, mehrarab@MSKCC.ORG

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