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Идёт набор NCT05893342

Frailty in the Perioperative Period

Наблюдательное Frailty

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: Preoperative frailty diagnostic.
Кому может быть актуально
Состояния в реестре: Frailty. Базовые параметры: от 65 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
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Perioperative Frailty and Postoperative Complications: a Prospective Study

Обзор

The presence of frailty is associated with a high risk of complications in the perioperative period, increasing morbidity and mortality, hospital stay, and loss of quality of life. In this prospective observational study, an evaluation of frailty was performed in patients older than 65 years old who undergo scheduled and urgent surgery. 138 patients are being included. The main objective is to evaluate the prevalence of frailty in patients older than 65 years undergoing surgery in our hospital and its association with postoperative mortality.

Подробное описание

The presence of frailty is associated with a high risk of complications in the perioperative period, increasing morbidity and mortality, hospital stay, and loss of quality of life. This is a prospective observational study in which an evaluation of frailty was performed in patients older than 65 years old who undergo scheduled and urgent surgery, including 138 patients. The main objective is to evaluate the prevalence of frailty in patients older than 65 years undergoing surgery and its association with postoperative mortality. The secondary objectives were the following: to assess the association between frailty and increased days of hospital stay, hospital readmission, and unexpected admission to ICU areas; to assess whether patients with greater frailty suffer a greater loss of postoperative functional independence; to evaluate type and frequency of complications; and to evaluate which scale is most useful to implement in the perioperative setting (Frailty Clinical Scale, Edmonton frailty test, Barthel Index, Mini-mental test, Charlson Index). Considering that the estimated percentage of frailty is 10%, with a 95% confidence interval and a 5% error margin, 138 patients are needed to accurately estimate the prevalence of frailty in the population.

Вмешательства

  • Диагностический тест Preoperative frailty diagnostic
    The preoperative evaluation of the patient will be carried out through the application of different scales that evaluate frailty (Edmonton frailty test, Barthel Index, Mini-mental test, Charlson Index) and a postoperative follow-up will be carried out for the diagnosis of complications during the first 90 postoperative days.

Первичные конечные точки

  • Prevalence of frailty [Срок оценки: First preoperative day]
  • Postoperative complications [Срок оценки: 90 postoperative days]
Вторичные конечные точки (2)
  • Postoperative evolution [Срок оценки: 90 postoperative days]
  • Functional independence [Срок оценки: First postoperative year]

Критерии участия

Критерии включения

  • Patients over 65 years old undergoing urgent or scheduled surgery

Критерии исключения

  • Language barrier
  • Cognitive impairment or inability to assist in clinical assessment during the study
  • Refusal to participate in the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 1 центр
  • Ángel Becerra — Las Palmas de Gran Canaria

Идентификаторы

NCT: NCT05893342 · 2019-343-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗