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Clinical Trials/NCT06650592
NCT06650592RecruitingNot Applicable

Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA

University of Chicago1 site in 1 country90 target enrollmentStarted: November 26, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
90
Locations
1
Primary Endpoint
The efficacy of immediate lymphatic reconstruction (ILR) based on objective circumference

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

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

All patients who were candidates for immediate lymphatic reconstruction (ILR) in the LYMPHA Database

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

Outcomes

Primary Outcomes

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 Outcomes

  • the impact of ILR on validated patient reported outcome tool using the lymphedema life impact scale (LLIS)(1 Day)
  • the impact of ILR on validated patient reported outcome tool using The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire(1 Day)
  • the impact of ILR on validated patient reported outcome tool using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)(1 Day)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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