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Идёт набор NCT06650592

Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA

— Наблюдательное Lymphatic Reconstruction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: All patients who were candidates for immediate lymphatic reconstruction (ILR).
Кому может быть актуально
Состояния в реестре: Lymphatic Reconstruction. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

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

Первичные конечные точки

  • The efficacy of immediate lymphatic reconstruction (ILR) based on objective circumference [Срок оценки: 1 Day]
  • the efficacy of immediate lymphatic reconstruction (ILR) based on volume [Срок оценки: 1 Day]
  • the efficacy of immediate lymphatic reconstruction (ILR) based on bioimpedance spectroscopy measurements of affected limbs of women in the prophylactic lymphedema database. [Срок оценки: 1 Day]
  • the efficacy of immediate lymphatic reconstruction (ILR) based on unaffected limbs of women in the prophylactic lymphedema database. [Срок оценки: 1 Day]
Вторичные конечные точки (3)
  • the impact of ILR on validated patient reported outcome tool using the lymphedema life impact scale (LLIS) [Срок оценки: 1 Day]
  • the impact of ILR on validated patient reported outcome tool using The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire [Срок оценки: 1 Day]
  • the impact of ILR on validated patient reported outcome tool using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) [Срок оценки: 1 Day]

Критерии участия

Критерии включения

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

Критерии исключения

  • None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • The University o Chicago — Chicago

Идентификаторы

NCT: NCT06650592 · IRB24-1513

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗