Electric Tubular Anastomosis in Rectal Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer; Anastomosis
• Intervention / Treatment: Device: traditional anastomotic device; Device: electric tubular anastomotic 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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: traditional anastomotic device	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.
Experimental: electric tubular anastomotic device	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate of anastomosis	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.	1 week after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time period of anastomosis		during the operation
time period of recovery	time of first postoperative defecation or exhausting	1 year after surgey

Collaborators and Investigators

• Sponsor: LI XIN-XIANG

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: May 7, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: electric tubular anastomotic device
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: FDCRC71-LXX

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No