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Идёт набор NCT05950438

Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy

— Наблюдательное Esophagectomy

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: Esophagectomy.
Кому может быть актуально
Состояния в реестре: Esophagectomy. Базовые параметры: 18 лет — 89 лет · 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
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Официальное название

A Prospective Clinical Registry Investigating Outcomes of Elective Robotic Transhiatal Esophagectomy

Обзор

The primary goal of this study is to collect short-term and long-term health outcomes of a robotic transhiatal esophagectomy procedure. Clinical (or health) outcomes measure the effect of the procedure on your overall health status. During this procedure, the surgeon will remove all or part of your esophagus. We want to identify patients who will have this procedure. We will look at data elements before, during, and after your procedure to understand the impact of this surgery on your post-operative clinical outcomes.

Подробное описание

Esophagectomy is a complex surgical procedure performed to treat various esophageal disorders. The surgery involves the removal of all or part of the esophagus and reconstruction using other parts of the gastrointestinal tract. Different surgical approaches and techniques have been developed, including open (transthoracic or transhiatal), minimally invasive (video-assisted thoracoscopic surgery or robotic-assisted), and hybrid approaches. These techniques may yield different clinical outcomes, and there is still ongoing debate regarding the optimal approach. Nevertheless, minimally invasive approaches, including robotic esophagectomy, are generally preferred given the lower morbidity. This prospective clinical registry aims to investigate outcomes of elective robotic transhiatal esophagectomy, the preferred approach at Northwestern Memorial Hospital, for adult patients undergoing this procedure. By collecting clinical and demographic data prospectively, we hope to identify factors that contribute to improved outcomes and guide future surgical practice.

Вмешательства

  • Процедура Esophagectomy
    Esophagectomy is a complex surgical procedure performed to treat various esophageal disorders. The surgery involves the removal of all or part of the esophagus and reconstruction using other parts of the gastrointestinal tract.

Первичные конечные точки

  • Number of Participants with Anastomotic Leak [Срок оценки: During first 3 months postop]
  • Number of Participants with Esophageal Stricture [Срок оценки: During first 3 months postop]
  • Number of Participants with Pneumonia [Срок оценки: During first 3 months postop]
  • Number of Participants Requiring Ventilation >48 Hours [Срок оценки: During first 3 months postop]
  • Number of Participants with Empyema [Срок оценки: During first 3 months postop]
  • Number of Participants with Pulmonary Embolism [Срок оценки: During first 3 months postop]
  • Number of Participants with Deep Venous Thrombosis [Срок оценки: During first 3 months postop]
  • Number of Participants with Gastric Outlet Obstruction [Срок оценки: During first 3 months postop]
  • Number of Participants with Stroke [Срок оценки: During first 3 months postop]
  • Number of Participants with Atrial Fibrillation [Срок оценки: During first 3 months postop]
Вторичные конечные точки (5)
  • Operative Time of Surgery [Срок оценки: Intraoperative]
  • Rates of Blood Loss [Срок оценки: Intraoperative]
  • Number of Participants with Conversion Rates to Open Esophagectomy [Срок оценки: Intraoperative]
  • Number of Participants with Lymph nodes in the Final Specimen [Срок оценки: Intraoperative]
  • Number of Participants with Proximal and Distal Margins [Срок оценки: Intraoperative]

Критерии участия

Критерии включения

  • Adult patients (18 years or older)
  • Patients undergoing elective esophagectomy for any indication
  • Patients who have already had an elective esophagectomy for any indication
  • Patients with consent providing capacity

Критерии исключения

  • Patients undergoing emergent esophagectomy
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners
  • Vulnerable Populations

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Northwestern University — Chicago

Идентификаторы

NCT: NCT05950438 · STU00219267

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗