Electric Tubular Anastomosis in Rectal Cancer

NCT ID: NCT05879172

Last Updated: 2023-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

traditional anastomotic device

Group Type: ACTIVE_COMPARATOR

traditional anastomotic device

Intervention Type: 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.

electric tubular anastomotic device

Group Type: EXPERIMENTAL

electric tubular anastomotic device

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LI XIN-XIANG

OTHER

Sponsor Role: lead

Responsible Party

LI XIN-XIANG

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

FDCRC71-LXX

Identifier Type: -

Identifier Source: org_study_id