Electric Tubular Anastomosis in Rectal Cancer
Application of Electric Tubular Anastomotic Device in Colorectal Tumor Surgery: a Multi-center Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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
|
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
Time Frame: 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.
|
1 week after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
time period of anastomosis
Time Frame: during the operation
|
during the operation
|
|
|
time period of recovery
Time Frame: 1 year after surgey
|
time of first postoperative defecation or exhausting
|
1 year after surgey
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDCRC71-LXX
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.