Menu
Recruiting NCT06650592

Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA

— Observational Lymphatic Reconstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: All patients who were candidates for immediate lymphatic reconstruction (ILR).
Who it may be relevant to
Registry conditions: Lymphatic Reconstruction. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Immediate lymphatic reconstruction (ILR) is a novel surgical approach performed at the time of initial lymph node dissection with the goal of preventing lymphedema. It involves the identification of lymphatic channels that are transected after lymph node dissection and microsurgical anastomosis of one or more lymphatic channel with a local recipient vein to re-direct upper extremity lymphatic drainage. Although ILR carries significant promise in prevention of lymphedema, there is a lack of high-level evidence supporting its efficacy because it is a novel surgical technique that is only offered at a few centers and not routinely covered by insurance carriers yet. The University of Chicago Comprehensive Cancer Center (UCCCC) is one of the busiest microsurgery centers performing this procedure, and, as a Lymphedema Center of Excellence, is in a unique position to investigate the efficacy of ILR in preventing lymphedema. In addition, the University has access to a world class microbiome research facility and colleagues. There is no information on the skin microbiome of the axilla in patients undergoing treatment for breast cancer or those at risk for developing lymphedema. Further exploratory studies such as this in a diverse patient population may lead to practice changing research in our approach to lymphedema management and prevention. The purpose of this study is to determine the role of immediate lymphatic reconstruction and obtain objective data to correlate the existing, self-reported rates of lymphedema at the University of Chicago.

Interventions

  • Other All patients who were candidates for immediate lymphatic reconstruction (ILR)
    All patients who were candidates for immediate lymphatic reconstruction (ILR)

Primary outcome measures

  • The efficacy of immediate lymphatic reconstruction (ILR) based on objective circumference [Time frame: 1 Day]
  • the efficacy of immediate lymphatic reconstruction (ILR) based on volume [Time frame: 1 Day]
  • the efficacy of immediate lymphatic reconstruction (ILR) based on bioimpedance spectroscopy measurements of affected limbs of women in the prophylactic lymphedema database. [Time frame: 1 Day]
  • the efficacy of immediate lymphatic reconstruction (ILR) based on unaffected limbs of women in the prophylactic lymphedema database. [Time frame: 1 Day]
Secondary outcome measures (3)
  • the impact of ILR on validated patient reported outcome tool using the lymphedema life impact scale (LLIS) [Time frame: 1 Day]
  • the impact of ILR on validated patient reported outcome tool using The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire [Time frame: 1 Day]
  • the impact of ILR on validated patient reported outcome tool using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) [Time frame: 1 Day]

Eligibility criteria

Inclusion criteria

  • All patients who were candidates for Immediate Lymphatic Reconstruction (ILR)

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • The University o Chicago — Chicago

Identifiers

NCT: NCT06650592 · IRB24-1513

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗