NCT01985698已完成不适用
A Single-centre, Prospective, Randomised, Controlled, Unblinded, Parallel-group Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for the Curative Treatment of Low Rectal Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 347
- 试验地点
- 1
- 主要终点
- postoperative complications
研究概览
简要总结
In this study, the investigators assessed the difference in efficacy and safety among robotic-assisted versus laparoscopic abdominoperineal resection for patients with low rectal cancer.
详细描述
Patients will be eligible for inclusion if their primary tumors is low rectal cancer.
Eligible patients will be randomly assigned to robotic-assisted (arm A) versus laparoscopic (arm B) abdominoperineal resection.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven rectal adenocarcinoma
- •Inferior edge of the tumor located within 5 cm from the anal verge as determined by colonoscopy withdrawing and digital rectal examination
- •No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc) according to ultrasound, CT, PET-CT, etc
- •Tumor assessed as cT1-T3 or ycT1-T3 after preoperative neoadjuvant chemoradiotherapy by pelvic MRI
- •No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
- •Suitable for both robot-assisted and laparoscopic surgery
- •American Society of Anesthesiologists (ASA) class I - III
- •No other preoperative treatment except neoadjuvant chemoradiotherapy
- •Informed consent
排除标准
- •Tumors assessed as cT1N0 and suitable for local excision
- •Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
- •More than one colorectal tumor
- •Familial Adenomatosis Polyposis, Lynch Syndrome, acute inflammatory bowel disease
- •Schedules need for other synchronous colon surgery
- •Absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class > III)
- •Pregnancy or lactation
- •Patients and/or family members can not understand and accept this study
- •Patients received chemoradiotherapy or other anti-tumor therapy before surgery
结局指标
主要结局
postoperative complications
时间窗: 30 days post operatively
postoperative complications related to operation
次要结局
- operative mortality(30 days post operatively)
- disease-free survival(3 years)
- overall survival(3 and 5 years)
- locoregional recurrence rate(3 and 5 years)
研究者
研究点 (1)
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