Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer (REAL): A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 1,240
- 试验地点
- 11
- 主要终点
- Locoregional recurrence rate
研究概览
简要总结
The purpose of this study is to evaluate the safety and oncological feasibility of robot-assisted surgery for mid/low rectal carcinoma compared with laparoscopic surgery.
详细描述
Laparoscopic surgery as the treatment for colon cancer has been widely recognized. But its use for rectal cancer is still controversial. Previous trials have shown that although the long-term survival outcomes were similar, laparoscopic surgery did not reach the non-inferiority in terms of local tumor radical resection, compared with open surgery. Robotic techniques are considered to improve the quality of surgery with three-dimensional vision, stable camera platform and flexible robotic arms. Meta-analyses have shown that compared with laparoscopic surgery, robotic surgery could improve surgical quality in terms of open conversion, circumferential resection margin, postoperative complications, postoperative recovery, and quality of life, with similar long-term survival. However, these evidences mainly came from retrospective studies and small-scale randomized controlled trials with low quality. There still needs high-quality clinical trials to confirm the advantages of 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
- •American Society of Anesthesiologists (ASA) class I - III;
- •Histologically proved rectal adenocarcinoma;
- •Inferior tumor edge ≤ 10 cm from anal verge, measured by rigid rectoscopy;
- •Tumor assessed as cT1-T3 (mesorectal fascia not involved) N0-1, or ycT1-T3 Nx after preoperative radio- or chemoradiotherapy, measured by pelvic MRI;
- •No evidence of distant metastases;
- •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 robotic and laparoscopic surgery;
- •Informed consent.
排除标准
- •Tumors assessed as clinical complete response after preoperative radio- or chemoradiotherapy;
- •Tumors assessed as cT1N0 and suitable for local excision;
- •Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery;
- •Multiple colorectal tumors or other schedules needing for synchronous colon surgery;
- •Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.);
- •Co-existent inflammatory bowel disease;
- •Pregnancy or lactation;
- •Patients received treatment other than preoperative radio- or chemoradiotherapy.
结局指标
主要结局
Locoregional recurrence rate
时间窗: 3 years after surgery
The proportion of patients with any cancer recurrence in the pelvic or perineal area
次要结局
- Circumferential resection margin positive rate(1 week after surgery)
- Postoperative complication rate(30 days after surgery)
- Disease-free survival time(3 years after surgery)
- Overall survival time(3 years after surgery)
- Rate of conversion to open surgery(Day 1)
- Operative time(Day 1)
- Estimated blood loss(Day 1)
- Proximal/distal resection margin(1 week after surgery)
- Self reported bladder function(At postoperative 3, 6 and 12 months)
- Self reported sexual function for female patients(At postoperative 3, 6 and 12 months)
- Number of retrieved lymph nodes(1 week after surgery)
- Postoperative hospital stay(30 days after surgery)
- Self reported sexual function for male patients(At postoperative 3, 6 and 12 months)
研究者
Xu jianmin
Head of Colorectal Surgery
Fudan University