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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 212
- 试验地点
- 4
- 主要终点
- Surgical success rate
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Single-Port Robotic Surgery
Patients with rectal cancer undergo single-port robotic surgery.
干预措施: Single-port robotic surgery (Procedure)
Multi-Port Robotic Surgery
Patients with rectal cancer undergo multi-port robotic surgery.
干预措施: Multi-port robotic surgery (Procedure)
结局指标
主要结局
Surgical success rate
时间窗: intraoperative
Proportion of robotic procedures not converted to laparoscopic or open surgery
次要结局
- Lymph node detection(14 days after surgery)
- Operative time(intraoperative)
- Intraoperative blood loss(intraoperative)
- Incision length(intraoperative)
- Total incision length(intraoperative)
- Length of stay(1-30 days after surgery)
- Postoperative recovery course(1-14 days after surgery)
- Early morbidity rate(30 days after surgery)
- Pain score(1-3 days after surgery)
- Tumor size(14 days after surgery)
- Incisal margin(14 days after surgery)
- Cosmetic effect(1 month, 6 months and 1 year after surgery)
- The quality of life-Colorectal(1 month, 6 months and 1 year after surgery)
- disease free survival rate(12 months after surgery)