Application of Electric Tubular Anastomotic Device in Colorectal Tumor Surgery: a Multi-center Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- success rate of anastomosis
研究概览
简要总结
Compared with traditional manual suturing, mechanical anastomosis can reduce the error caused by human factors. The electric anastomotic device can improve the automation and accuracy of anastomosis, reduce the requirements for doctors' operation, and establish a more standardized usage specification, thereby reducing the surgical complication rate and improving the quality of anastomosis. The clinical study of electric tubular anastomotic device adopts a multicenter, randomized, parallel controlled non-inferior study design, and randomly groups according to the 1:1 ratio to evaluate the clinical effectiveness and safety of electric tubular anastomotic device compared with conventional manual device.
详细描述
Compared with traditional manual suturing, mechanical anastomosis can reduce the error caused by human factors, involving the advantages like simple operation, short operation time, fast postoperative recovery, etc. Mechanical anastomosis can also ensure the consistency and repeatability of the surgical anastomosis process. The electric anastomotic device can improve the automation and accuracy of anastomosis, reduce the requirements for doctors' operation, and establish a more standardized usage specification, thereby reducing the surgical complication rate and improving the quality of anastomosis.
The clinical study of electric tubular anastomotic device adopts a multicenter, randomized, parallel controlled non-inferior study design, and randomly groups according to the 1:1 ratio to evaluate the clinical effectiveness and safety of electric tubular anastomotic device compared with conventional manual device.
The effectiveness of the electric tubular anastomotic device was evaluated by taking the success rate of anastomosis and anastomosis-related adverse events as the main evaluation indexes, while the operation performance evaluation, operation time, anastomosis time and postoperative recovery as the secondary evaluation indicators. The safety of electric tubular anastomotic device was evaluated by adverse events, vital signs, laboratory tests, etc.
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
- •Age: 18-80y;
- •Patients with resectable rectal cancer who are scheduled to undergo Dixon surgery (definition of rectal cancer: the lower boundary of the tumor is 10 cm from the anus≤);
- •The patient consents to participate in the clinical study and signs the informed consent form.
排除标准
- •Patients with significant local or systemic severe infection;
- •Acute abdomen: intestinal obstruction, peritonitis, intestinal perforation;
- •Have a systemic underlying disease that has not been controlled, or is unstable; Patients with poor constitution or serious other organic diseases who cannot tolerate anesthesia and surgery;
- •Women during pregnancy, perinatal and lactation;
- •Patients who are mentally incapable or unable to understand the requirements of the study;
- •Patients who participated in other clinical studies 6 weeks before the start of this study or at the same time;
- •The life expectancy of patients with malignant tumors is less than 6 months;
- •Those who are critically ill and find it difficult to make an accurate evaluation of the effectiveness and safety of the device;
- •Patients with diseases who are believed not suitable to participate in this clinical study;
- •Have other diseases that are against anastomosis;
- •The patient is receiving hormone therapy or immunosuppressive therapy;
- •Albumin< 30g/dl.
结局指标
主要结局
success rate of anastomosis
时间窗: 1 week after surgery
The end-to-end and end-to-side anastomosis of the intestinal tissue is performed during the operation. After the performance of anastomosis, the instrument is withdrawn. The anastomosis should be checked of accuracy, completeness and bleeding.
次要结局
- time period of anastomosis(during the operation)
- time period of recovery(1 year after surgey)
研究者
LI XIN-XIANG
Professor
Fudan University