跳至主要内容
临床试验/NCT06650592
NCT06650592招募中不适用

Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA

University of Chicago1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年11月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
The efficacy of immediate lymphatic reconstruction (ILR) based on objective circumference

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

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

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

干预措施: All patients who were candidates for immediate lymphatic reconstruction (ILR) (Other)

结局指标

主要结局

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

时间窗: 1 Day

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

时间窗: 1 Day

the efficacy of immediate lymphatic reconstruction (ILR) based on bioimpedance spectroscopy measurements of affected limbs of women in the prophylactic lymphedema database.

时间窗: 1 Day

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

时间窗: 1 Day

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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