ImpRovEd Care After eSophageCtomy Using an Algorithm for postoperativE Complications - RESCUE Trial

Обзор

The objective of the RESCUE-trial is to investigate whether implementation of a consensus-based clinical care algorithm to standardize diagnosis and management of postoperative complications reduces 90-day mortality, ICU (re)admission and surgical interventions after esophagectomy for esophageal cancer.

Вмешательства

• Другое Wash-in period
  The goal of the wash-in period between the control and intervention period is to intensively educate and train physicians to use the algorithm as intended during daily postoperative care. The coordinating investigator along with the local principal investigator will be responsible for this training. Training will be performed in a standardized approach in order to guarantee uniformity across centres.
• Диагностический тест Algorithm-based care
  During the intervention period, (participating) patients will receive algorithm-based care. The RESCUE algorithm is a consensus-based clinical care algorithm developed to standardize postoperative care. The algorithm includes the same modalities as applied in usual care, and does not include novel/experimental modalities, but rather offers a novel, standardized approach to guide the use of common modalities during postoperative care. The daily objective evaluation of patients' condition, vital s

Первичные конечные точки

• Severe complications [Срок оценки: 90 days]

Вторичные конечные точки (11)

• General quality of life [Срок оценки: 6 weeks, and 3, 6, and 12 months after esophagectomy]
• Time to functional recovery [Срок оценки: 90 days after esophagectomy]
• Comprehensive Complications index [Срок оценки: 90 days after esophagectomy]
• Failure to rescue [Срок оценки: 90 days after esophagectomy]
• Length of hospital (intensive care unit) stay [Срок оценки: 90 days after esophagectomy]
• Succes of algorithm implementation [Срок оценки: 90 days after esophagectomy]
• Economic evaluation [Срок оценки: 3,6 and 12 months after esophagectomy]
• Productivity losses [Срок оценки: 3,6 and 12 months after esophagectomy]
• Budget Impact Analysis [Срок оценки: 3,6 and 12 months after esophagectomy]
• Cancer-specific quality of life [Срок оценки: 6 weeks, and 3, 6, and 12 months after esophagectomy]
• Esophageal cancer-specific quality of life [Срок оценки: 6 weeks, and 3, 6, and 12 months after esophagectomy]

Критерии участия

Критерии включения

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• Age ≥ 18 years
• Histologically proven esophageal or gastro-esophageal junction carcinoma (cT1-4aN0-3M0)
• Scheduled to undergo curatively-intended esophagectomy with gastric tube reconstruction. All techniques (i.e. minimally invasive, robotic, hybrid, open) and approaches (i.e. transthoracic, transcervical, transhiatal) of esophagectomy are suitable for inclusion.
• Ability to provide written informed consent

Критерии исключения

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• Emergency resection
• Patients who underwent (additional) total gastrectomy
• Patients who underwent reconstruction using colonic or jejunal interposition
• Patients in whom no anastomosis is created during resection
• Secondary malignancy which determines prognosis

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06762652 · 2024-17562 · 10390032310024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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