Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy
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: Robotic right hemicolectomy, Laparoscopic right hemicolectomy.
- Кому может быть актуально
- Состояния в реестре: Colorectal Neoplasms, Colorectal Neoplasms Malignant, Colorectal Neoplasms, Benign, Colorectal Cancer. 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
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Robotic Right Hemicolectomy With Intracorporeal Anastomosis Versus Laparoscopic Right Hemicolectomy With Extracorporeal Anastomosis (PRORHEM): a Randomized Controlled Trial
Обзор
Robotic right hemicolectomy with intra-corporeal anastomosis may have better short-term recovery outcomes and decreased incidence of incisional hernia when compared to the laparoscopic actual standard of care, for similar safety outcomes.
Подробное описание
During laparoscopic right hemicolectomy (lapRHC) for cancer or polyp, intra-corporeal anastomosis (ICA) offers better short-term recovery and decreased incidence of incisional hernia (IH) when compared to extra-corporeal anastomosis (ECA). However, because of the technical limitations of laparoscopy, ICA has not gained in wide acceptance and ECA has remained the standard of care. On the contrary, robotics offers improved suturing capacities and facilitates the realization of ICA. Therefore, robotic right hemicolectomy (robRHC) with ICA may have better short-term recovery outcomes and decreased incidence of IH when compared to the laparoscopic actual standard of care. In a randomized controlled trial, we will compare robRHC with ICA with lapRHC with ECA, in terms of recovery of bowel function (time to first passage of faeces). Secondary outcomes will notably include length of stay, incidence of IH, patient-reported esthetical outcomes and safety outcomes (morbidity, mortality, proximal and distal margins, harvested lymph nodes).
Вмешательства
- Процедура Robotic right hemicolectomy
Robotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section, using the Da Vinci Xi. - Процедура Laparoscopic right hemicolectomy
Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline.
Первичные конечные точки
- Time to first passage of faeces [Срок оценки: From index surgical procedure (skin closure) until time of first passage of faeces, during hospitalisation, on average during the first 7 post-operative days]
Вторичные конечные точки (12)
- Duration of surgery [Срок оценки: From skin incision to skin closure, during index surgical procedure]
- Blood loss [Срок оценки: From skin incision to skin closure, during index surgical procedure]
- Intra-operative transfusion [Срок оценки: From skin incision to skin closure, during index surgical procedure]
- Intra-operative complication [Срок оценки: From skin incision to skin closure, during index surgical procedure]
- Conversion to open surgery [Срок оценки: From skin incision to skin closure, during index surgical procedure]
- Length of the extraction site [Срок оценки: At post-operative day 30]
- Creation of a stoma [Срок оценки: From skin incision to skin closure, during index surgical procedure]
- Hb, WBC and CRP [Срок оценки: At post-operative day 1, post-operative day 2, post-operative day 3, post-operative day 4 and post-operative day 5]
- Time to first passage of flatus [Срок оценки: From index surgical procedure (skin closure) until time of first passage of flatus, during hospitalisation, on average during the first 7 post-operative days]
- In-hospital postoperative ileus [Срок оценки: During hospitalisation, on average during the first 5 post-operative days]
- Length of stay [Срок оценки: From the first day of hospitalisation to the day of discharge, on average during the first 10 post-operative days]
- Post-operative morbidity [Срок оценки: From index surgical procedure (skin closure) to post-operative day 30]
Критерии участия
Критерии включения
- Adult patients requiring elective minimally invasive RHC for cT1-T3 Nx M0 cancer of the right colon (including cancer of the appendix, caecum, ascending colon and hepatic flexure).
Критерии исключения
- Not scheduled for minimally invasive RHC (refuses surgery and/or planned open approach)
- Emergency surgery
- Hereditary colorectal cancer
- Inflammatory bowel disease
- Synchronous resection of (an)other organ(s)
- Synchronous surgical procedure (including more extended resection of the lower gastrointestinal tract)
- cT4
- cM+
- History of laparotomy
- Pregnancy
- No anastomosis planned
- Unable to provide informed consent
- No informed consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Публикации
- Meyer J, Liot E, Meurette G, Toso C, Ris F. Robotic right hemicolectomy with intracorporeal anastomosis versus laparoscopic right hemicolectomy with extracorporeal anastomosis (PRORHEM): protocol for a randomized controlled trial. BMC Surg. 2026 Jul 8. doi: 10.1186/s12893-026-03990-1. Online ahead of print. PMID 42420958
Идентификаторы
NCT: NCT06067620 · PRORHEM