NCT05879172

Electric Tubular Anastomosis in Rectal Cancer

Application of Electric Tubular Anastomotic Device in Colorectal Tumor Surgery: a Multi-center Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: LI XIN-XIANG · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anastomosis
• Rectal Cancer

Interventions

Type	Name	Description
DEVICE	electric tubular anastomotic device	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.
DEVICE	traditional anastomotic device	Traditional anastomosis is used in this group. Staplers of the same brand are uniformly adopted to avoid differences between groups caused by different brands.

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-07-31
• Completion: 2023-03-31
• First posted: 2023-05-30
• Last updated: 2023-05-30

Locations

1 site across 1 country: China