Clinical trial NCT06650592: Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA
Official title: Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphatic Reconstruction
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The University of Chicago has a prospectively maintained database (LYMPHA Database) of all patients who were candidates for ILR.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: The efficacy of immediate lymphatic reconstruction (ILR) based on objective circumference
timeFrame: 1 Day
measure: the efficacy of immediate lymphatic reconstruction (ILR) based on volume
timeFrame: 1 Day
measure: the efficacy of immediate lymphatic reconstruction (ILR) based on bioimpedance spectroscopy measurements of affected limbs of women in the prophylactic lymphedema database.
timeFrame: 1 Day
measure: the efficacy of immediate lymphatic reconstruction (ILR) based on unaffected limbs of women in the prophylactic lymphedema database.
timeFrame: 1 Day
Secondary outcomes:
measure: the impact of ILR on validated patient reported outcome tool using the lymphedema life impact scale (LLIS)
timeFrame: 1 Day
measure: the impact of ILR on validated patient reported outcome tool using The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: 1 Day
measure: the impact of ILR on validated patient reported outcome tool using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
timeFrame: 1 Day
Other outcomes:
measure: Axillary skin swabs of each axilla for microbiome analysis
timeFrame: 1 Day
Locations:
city: Chicago
country: United States
facility: The University o Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Summer Hanson, MD, PhD, FACS
role: PRINCIPAL_INVESTIGATOR
References: