Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Colorectal Surgery, Benign or Malignant Rectal or Colon Tumors. 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
- Бельгия, Франция, Германия, Италия, Нидерланды +3
- 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
Low Stable Pressure Pneumoperitoneum in Colorectal Surgery : An Ideal Stage 2b Prospective International Cohort Study (CROSS STUDY)
Обзор
The objective of this prospective, international cohort is to incorporate the low stable pressure (using Airseal Insufflator) approach and its associated parameters into the early rehabilitation program after colorectal surgery so as to shorten hospitalization up to the ambulatory care and reduce postoperative pain and opioid consumption.
Подробное описание
Laparoscopy is currently the gold standard for the vast majority of abdominal surgeries, and especially for colectomy for cancer or benign diseases. There are many data showing the benefits of the laparoscopic approach to colectomy in terms of morbidity, post-operative pain and analgesic consumption, length of hospital stay, cosmetic results, and improved patient satisfaction. In 2002, consensus European guidelines recommended insufflating at the lowest pressure that still provides sufficient exposure. Considering these results, low-pressure laparoscopy is one of the alternatives that have been developed to do away with the complications of the pneumoperitoneum while retaining its advantages.
However, other factors may influence the outcomes of the low-pressure pneumoperitoneum such as the use of humidification and warming gaz, robotic or microsurgical instrumentation, neuromuscular blockade, patient positioning, pre-stretching of the abdominal wall, ventilation-induced changes, and probably individual patient factors like obesity. These parameters could not be separately tested in randomized trial. We should consider all these parameters in a prospective international registry in order to optimize the benefit of low-pressure pneumoperitoneum in post-operative recovery.
Первичные конечные точки
- To assess the impact of the stable low-pressure approach (using Airseal Insufflator) and its associated parameters into the the early rehabilitation program after colorectal surgery on length of stay. [Срок оценки: From the surgery to the end of the hospitalization (max 30 days)]
Вторичные конечные точки (6)
- The impact of stable low pressure on the postoperative pain after colorectal surgery [Срок оценки: At 24 hours after the end of the surgery]
- The impact of stable low pressure on the opioid consumption after colorectal surgery [Срок оценки: From the surgery to the end of the hospitalization (max 30 days)]
- The impact of the different mini-invasive approaches on the feasibility and benefit of low stable pressure [Срок оценки: From the surgery to the end of the hospitalization (max 30 days)]
- The Post-operative Surgical and Medical morbidity [Срок оценки: From the surgery to the end of the hospitalization (max 30 days)]
- The impact of the anesthetic management on the feasibility and benefit of low stable pressure [Срок оценки: From the surgery to the end of the hospitalization (max 30 days)]
- The Surgical and Medical morbidity at 30 days [Срок оценки: At 30 days after the end of the surgery]
Критерии участия
Критерии включения
- Age ≥ 18 years old
- Colonic resection (right or left, subtotal or total) performed for benign or malignant pathology
- Rectal resection with or without stoma for benign or malignant pathology
- Laparoscopic or robotic procedure
- Surgery under low stable pressure pneumoperitoneum with AirSeal
- Patient who benefits by medicare system
- Oral agreement after reading information letter
Критерии исключения
- Laparotomy procedure
- Associated resection (except appendectomy or liver biopsy)
- Transverse colectomy
- Emergency procedure
- Pelvic sepsis
- Pregnancy or breast feeding period
- Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to agree to participate in the study
- Persons deprived of liberty or under guardianship
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 11 центров
- Hôpital Jean Minoz — Besançon
- Clinique Tivoli-Ducos - Bordeaux Colorectal Institute — Bordeaux
- Hôpital Albert Michallon — La Tronche
- Hôpital Bicêtre — Le Kremlin-Bicêtre
- Hôpital Nord-Marseille — Marseille
- Clinique Hartmann — Neuilly-sur-Seine
- Hopital Saint-Louis — Paris
- Hôpital Saint-Antoine — Paris
- … и ещё 3 центра
Бельгия · 1 центр
- Universitair Ziekenhuis — Jette
Германия · 1 центр
- St. Georg Klinikum Eisenach — Eisenach
Италия · 1 центр
- Division of Colon and Rectal Surgery — Milan
Нидерланды · 1 центр
- Academic Medical Center — Amsterdam
Испания · 1 центр
- Hospital General Universitario Gregorio — Madrid
Швейцария · 1 центр
- Hôpitaux Universitaires de Genève — Geneva
Великобритания · 1 центр
- Nhs Fundation Trust — Manchester
Идентификаторы
NCT: NCT06154785 · B.C.I.A 2023/01