Cost-Effectiveness and Outcome of Robot-assisted Vs Laparoscopic Roux-en-Y Gastric Bypass
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: Laparoscopic and robotic (DaVinci) RYGB.
- Кому может быть актуально
- Состояния в реестре: Morbid Obesity. Базовые параметры: 18 лет — 75 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
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Cost-Effectiveness and Outcome of Robot-assisted Vs Laparoscopic Roux-en-Y Gastric Bypass: A Non-inferiority Randomized Controlled Trial
Обзор
The objective of this randomized controlled trial is to compare perioperative outcomes between laparoscopic and robotic approaches in patients with severe obesity who are candidates for RYGB. The trial aims to address the following key questions: To evaluate the difference between the two procedures in terms of postoperative complications. To assess intraoperative complications, conversion rate, mortality, operative times, postoperative hospital stay, and cost analysis for both approaches. In summary, the researchers will compare the laparoscopic and robotic approaches to determine which one leads to better perioperative outcomes
Подробное описание
Treating patients with pathological obesity has always posed a challenge for bariatric surgeons due to their increased risk of post-operative complications and varying short-term outcomes depending on the chosen procedure. Currently, there are no established guidelines to dictate which procedure is optimal for a given clinical presentation. Surgeons typically make this decision based on their expertise and the patient's characteristics. The most frequently performed procedures worldwide are sleeve gastrectomy and Roux-en-Y gastric bypass, with the latter validated by numerous long-term studies as a safe and effective bariatric and metabolic option for patients with a BMI \<50 kg/m2. However, the complexity of Roux-en-Y gastric bypass, which requires the creation of two anastomoses during the reconstruction phase, which might be challenging when performed laparoscopically, may be facilitated by a robotic approach. Although some studies suggest that these approaches have equivalent safety and efficacy profiles, conclusive evidence evaluating their economic impact remains elusive. Consequently, the objective of the present study is to compare morbidity between the laparoscopic and robotic approach in patients undergoing Roux-en-Y gastric bypass.
Вмешательства
- Устройство Laparoscopic and robotic (DaVinci) RYGB
Laparoscopic and robotic (DaVinci) Roux-en-Y Gastric Bypass
Первичные конечные точки
- Early complications rate [Срок оценки: 30 Days after hospital discharge]
Вторичные конечные точки (6)
- Intraoperative complications rate [Срок оценки: From the beginning to the end of the surgical procedure]
- Conversions rate [Срок оценки: From the beginning to the end of the surgical procedure]
- mortality rate [Срок оценки: 30 days after hospital discharge]
- Operative time [Срок оценки: From the beginning to the end of the surgical procedure]
- Length of hospital stay [Срок оценки: up to 1 week]
- Costs of hospitalization and surgery [Срок оценки: up to 1 week]
Критерии участия
Критерии включения
- Age 18 years or older
- Patients who are candidates for Roux-en-Y gastric bypass using a minimally invasive technique
- Informed consent has been given.
Критерии исключения
- patients who are candidates for bariatric procedures other than Roux-en-Y gastric bypass, or to those who require a laparotomy for Roux-en-Y gastric bypass surgery.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Италия · 1 центр
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma
Идентификаторы
NCT: NCT07153419 · 5186