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Набор скоро начнётся NCT07202442

Robotic Emergency General Surgery Program

Наблюдательное Emergency General Surgery

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: Emergency General surgery patients with robotic approach for the surgery.
Кому может быть актуально
Состояния в реестре: Emergency General Surgery. Базовые параметры: от 18 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Beginning of Robotic Emergency General Surgery Program at Nice University Hospital

Обзор

Background Abdominal surgical emergencies account for 20-30% of visceral surgery procedures. However, these emergencies are responsible for more than half of the morbidity in our discipline, with a surgical site infection rate four times higher than in elective surgery, and significantly higher rates of surgical revision and conversion (PMID: 34225343 and 27016997 and 27120712). In cases where minimally invasive surgery is converted to laparotomy, patients are three times more likely to be admitted to critical care units (PMID: 39966134). Visceral surgery currently represents the largest and fastest-growing discipline in robotic surgery. Robotic management of emergency general surgery has been described in the literature for several years, particularly in the United States. Robotic surgery allows a shift from open procedures to minimally invasive techniques or simplifies complex laparoscopic procedures. Several literature reviews and meta-analyses report decreased laparotomy rates, reduced perioperative morbidity, and shorter average length of hospital stay (PMID: 38446451 and 38918109). Abdominal surgical emergencies account for 20-30% of visceral surgery procedures. However, these emergencies are responsible for more than half of the morbidity in our discipline, with a surgical site infection rate four times higher than in elective surgery, and significantly higher rates of surgical revision and conversion (PMID: 34225343 and 27016997 and 27120712). In cases where minimally invasive surgery is converted to laparotomy, patients are three times more likely to be admitted to critical care units (PMID: 39966134). Visceral surgery currently represents the largest and fastest-growing discipline in robotic surgery. Robotic management of emergency general surgery has been described in the literature for several years, particularly in the United States. Robotic surgery allows a shift from open procedures to minimally invasive techniques or simplifies complex laparoscopic procedures. Several literature reviews and meta-analyses report decreased laparotomy rates, reduced perioperative morbidity, and shorter average length of hospital stay (PMID: 38446451 and 38918109).Primary Objective:To assess the implementation of a robotic surgery program for emergency visceral procedures (proof of feasibility in our university hospital). Secondary Objectives: Reduce perioperative morbidity, Reduce the rate of laparotomy, Reduce the average length of hospital stay (LOS), Reduce postoperative admission to critical care, Reduce operative time.

Вмешательства

  • Процедура Emergency General surgery patients with robotic approach for the surgery
    vPrimary Endpoint: The proportion of procedures performed robotically versus laparoscopically or via laparotomy for selected indications. Secondary Endpoints: A 5% change in perioperative morbidity, laparotomy rate, LOS, critical care admission rate, and operative time. Included Pathologies (for patients eligible for laparoscopy) : Acute cholecystitis with predictors of intraoperative difficulty. Bowel obstruction requiring bowel resection (in presence of CT signs of visceral compromise: poor en

Первичные конечные точки

  • Implementation of a robotic surgery program for emergency visceral procedures [Срок оценки: Postoperative day 30]
Вторичные конечные точки (5)
  • Evaluating robotic general emergencies procedures (Change perioperative morbidity) [Срок оценки: Postoperative day 30.]
  • Evaluating robotic general emergencies procedures (Change the rate of laparotomy) [Срок оценки: Postoperative day 30]
  • Evaluating robotic general emergencies procedures (Change the average length of hospital stay ) [Срок оценки: Postoperative day 30]
  • Evaluating robotic general emergencies procedures (Change postoperative admission to critical care) [Срок оценки: Postoperative day 30]
  • Evaluating robotic general emergencies procedures (Change operative time) [Срок оценки: Postoperative day 30]

Критерии участия

Критерии включения

  • Acute cholecystitis with predictors of intraoperative difficulty.
  • Bowel obstruction requiring bowel resection (in presence of CT signs of visceral compromise: poor enhancement of bowel loops, pneumoperitoneum).
  • Complicated acute diverticulitis with perforation and peritonitis.
  • Penetrating abdominal trauma with hemodynamic stability requiring surgery (e.g., bowel resection-anastomosis).
  • Right or left colectomy for other etiologies.
  • Splenectomy in hemodynamically stable or embolized patients.

Критерии исключения

  • Hemodynamic instability.
  • Uncomplicated acute appendicitis.
  • Acute cholecystitis without predictors of intraoperative difficulty.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • CHU de NICE — Nice

Идентификаторы

NCT: NCT07202442 · 25Urgences01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗