Safety and Efficacy Study of Single-port Robotic Versus Multi-port Robotic Radical Rectal Cancer 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: Single-port robotic surgery, Multi-port robotic surgery.
- Кому может быть актуально
- Состояния в реестре: Rectal Cancer, Surgery. Базовые параметры: 18 лет — 80 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
- Китай
- 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
Safety and Efficacy Study of Single-port Robotic Versus Multi-port Robotic Radical Rectal Cancer Surgery: A Multi-center, Prospective, Open Label, Non-inferiority, Randomized Controlled Trial
Обзор
This study is designed to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.
Подробное описание
Surgical robots were born in the 1980s and have the advantages of being precise, flexible, less invasive and remotely operable than traditional surgical methods. The single-port robot is a further extension of minimally invasive surgery by placing multiple instruments through a single incision. Most studies have reported on the perioperative outcomes of robotic versus conventional laparoscopic surgery in the treatment of colorectal cancer. However, there are limited data comparing the perioperative outcomes of single-port robotics and multi-port robotics in the treatment of colorectal cancer，especially in rectal cancer surgery. The purpose of this study is to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.
Вмешательства
- Процедура Single-port robotic surgery
In this group, patients will be operated using a single-port surgical robot system. In the single-port configuration, a four-channel trocar shall be used. The surgical tools are steered through the curved access channels in the trocar to enter a patient's abdomen. The surgical procedure followed the principle of total mesorectal excision. - Процедура Multi-port robotic surgery
In this group, patients will be operated using a multi-port surgical robot system. Surgical instruments enter the abdominal cavity through 4 separate trocars. The surgical procedure followed the principle of total mesorectal excision.
Первичные конечные точки
- Surgical success rate [Срок оценки: intraoperative]
Вторичные конечные точки (12)
- Operative time [Срок оценки: intraoperative]
- Intraoperative blood loss [Срок оценки: intraoperative]
- Incision length [Срок оценки: intraoperative]
- Total incision length [Срок оценки: intraoperative]
- Length of stay [Срок оценки: 1-30 days after surgery]
- Postoperative recovery course [Срок оценки: 1-14 days after surgery]
- Early morbidity rate [Срок оценки: 30 days after surgery]
- Pain score [Срок оценки: 1-3 days after surgery]
- Tumor size [Срок оценки: 14 days after surgery]
- Incisal margin [Срок оценки: 14 days after surgery]
- Lymph node detection [Срок оценки: 14 days after surgery]
- Cosmetic effect [Срок оценки: 1 month, 6 months and 1 year after surgery]
Критерии участия
Критерии включения
- 18 years < age ≤80 years
- Tumor located in the mid to high rectum (lower edge of tumor ≥ 5 cm from anal verge)
- Pathological rectal carcinoma
- Clinically diagnosed c/ycT1-3N0-1M0 lesions according to the 8th Edition of AJCC Cancer Staging Manual
- Tumor size of 10 cm or less
- No history of other malignant tumors
- ECOG score is 0-1
- ASA score is Ⅰ-Ⅲ
- Informed consent
Критерии исключения
- Body mass index (BMI) >35 kg/m2
- Familial adenomatous polyposis (FAP)
- Inflammatory bowel disease (IBD)
- Multiple malignant colorectal tumors
- Pregnant woman or lactating woman
- Severe mental disease
- Previous gastrointestinal surgery (except appendectomy ）
- Combination of intestinal obstruction, bleeding, perforation requiring emergency surgery
- Requirement of simultaneous surgery for other disease
- Serious disorders of liver and kidney function, coagulation function, or severe underlying diseases that cannot tolerate the surgery.
- Patients or family members who cannot understand the study program.
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
- Открытое
- Основная цель
- Лечение
Центры проведения
Китай · 4 центра
- The First Affiliated Hospital of Henan University of Science & Technology — Luoyang
- Shandong Provincial Hospital Affiliated to Shandong First Medical University — Цзинань
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Шанхай
- The First Affiliated Hospital of Wenzhou Medical University — Wenzhou
Публикации
- Guo Z, Shi Y, Song Z, Jia W, Wang S, Zhang Y, Ji X, Liu K, Zhang T, Cheng X, Zhao R. Single-incision robotic assisted surgery: a nonrandomized cohort pilot study on a novel surgical platform in colorectal surgery. Int J Surg. 2023 Nov 1;109(11):3417-3429. doi: 10.1097/JS9.0000000000000612. PMID 37526117
Идентификаторы
NCT: NCT06943690 · RASILS-01