Electric Tubular Anastomosis in Rectal Cancer
Condition: Anastomosis; Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): electric tubular anastomotic device; traditional anastomotic device
Intervention type(s): Device; Device
Intervention description(s): The electric tubular anastomotic device developed by Suzhou Yingtukang Medical Technology Co., Ltd. is used for colorectal end-to-end and end-to-side anastomosis. This product is suitable for open or minimally invasive colorectal cancer surgery.
Before firing the device, tissue thickness should be carefully assessed to prevent poor staling leading to leakage, inadequate hemostasis, or poor treatment.; Traditional anastomosis is used in this group. Staplers of the same brand are uniformly adopted to avoid differences between groups caused by different brands.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: electric tubular anastomotic device