Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Chicago

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

The University of Chicago has a prospectively maintained database (LYMPHA Database) of all patients who were candidates for ILR.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

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

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: All patients who were candidates for immediate lymphatic reconstruction (ILR)1 intervention

Trial outcomes

Primary outcomes

1

The efficacy of immediate lymphatic reconstruction (ILR) based on objective circumference

Time frame
1 Day
2

the efficacy of immediate lymphatic reconstruction (ILR) based on volume

Time frame
1 Day
3

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
4

the efficacy of immediate lymphatic reconstruction (ILR) based on unaffected limbs of women in the prophylactic lymphedema database.

Time frame
1 Day

Secondary outcomes

1

the impact of ILR on validated patient reported outcome tool using the lymphedema life impact scale (LLIS)

This is an 18 questionnaire that has a scale from 0 (no pain) to 4 (severe pain)

Time frame
1 Day
2

the impact of ILR on validated patient reported outcome tool using The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire

This is a 30 questionnaire that has a scale from 1 (No difficulty) to 5 (unable)

Time frame
1 Day
3

the impact of ILR on validated patient reported outcome tool using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)

This is a 17 questionnaire that scales from unable to do it to not difficult.

Time frame
1 Day

Other outcomes

1

Axillary skin swabs of each axilla for microbiome analysis

Characterize the axillary microbiome in limbs that have been treated with ILR compared to those that were unaffected.

Time frame
1 Day

Sponsors and contacts

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