Skip to content

Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA

Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06650592
Enrollment
90
Registered
2024-10-21
Start date
2024-11-26
Completion date
2029-10-01
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphatic Reconstruction

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.

Interventions

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

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

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
The efficacy of immediate lymphatic reconstruction (ILR) based on objective circumference1 Day
the efficacy of immediate lymphatic reconstruction (ILR) based on volume1 Day
the efficacy of immediate lymphatic reconstruction (ILR) based on bioimpedance spectroscopy measurements of affected limbs of women in the prophylactic lymphedema database.1 Day
the efficacy of immediate lymphatic reconstruction (ILR) based on unaffected limbs of women in the prophylactic lymphedema database.1 Day

Secondary

MeasureTime frameDescription
the impact of ILR on validated patient reported outcome tool using the lymphedema life impact scale (LLIS)1 DayThis is an 18 questionnaire that has a scale from 0 (no pain) to 4 (severe pain)
the impact of ILR on validated patient reported outcome tool using The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire1 DayThis is a 30 questionnaire that has a scale from 1 (No difficulty) to 5 (unable)
the impact of ILR on validated patient reported outcome tool using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)1 DayThis is a 17 questionnaire that scales from unable to do it to not difficult.

Countries

United States

Contacts

CONTACTSummer Hanson, MD, PhD, FACS
sehanson@bsd.uchicago.edu(773) 702-6302
CONTACTLeila Yazdanbakhsh
leila.yazdanbakhsh@bsd.uchicago.edu773-834-5087
PRINCIPAL_INVESTIGATORSummer Hanson, MD, PhD, FACS

University of Chicago

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026