Cholecystitis Clinical Trial
Official title:
Prospective, Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trial Protocol for the Safety and Efficacy of Clinical Applications of the Endoscopic Instrument Control System
Verified date | October 2021 |
Source | The Third Xiangya Hospital of Central South University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective, multi-center, randomized, single-blind, parallel-controlled clinical trial to evaluate the safety and efficacy of the Chinese domestic endoscopic instrument control system in clinical treatment.
Status | Completed |
Enrollment | 168 |
Est. completion date | October 1, 2021 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. 18-65 years old, male or female 2 .American Society of Anesthesiologists (ASA): Level 1, Level 2 or Level 3 3. BMI 18-30Kg/m2 4. Benign gallbladder diseases such as acute or chronic cholecystitis, gallstones and polypoid lesions of gallbladder 5. Subjects or their legal representatives/guardians voluntarily participate in clinical trials and have signed informed consent form Exclusion Criteria: 1. Participating in any other clinical trial within 30 days before signing the informed consent form 2. Pregnancy or lactation 3. With a history of epilepsy or psychosis 4. With a history of previous operations at related sites 5. Severe cardiovascular and cerebrovascular diseases with New York grade III-IV cardiac function or pulmonary insufficiency that can't tolerate the operation 6. Severe liver and kidney insufficiency such as cirrhosis and renal failure 7. Acute cholecystitis lasting for more than 72 hours, acute cholecystitis with severe complications such as cholecystitis, gangrene, perforation, etc., and gallbladder thickness thicker than 10 mm 8. Acute cholangitis, gallstone with acute pancreatitis, primary common bile duct stones, intrahepatic bile duct stones and obstructive jaundice 9. Gallbladder cancer or protuberant lesions are suspected to be cancerous 10. Severe allergic constitution and suspected or identified addicts to alcohol or drugs 11. Abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastatic diseases 12. Other situations that researchers consider it inappropriate to participate in this clinical trial |
Country | Name | City | State |
---|---|---|---|
China | The Third Xiangya Hospital of Central South University | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
The Third Xiangya Hospital of Central South University | The Affiliated Hospital of Qingdao University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | surgical success rate | The surgical success rate is defined as the proportion of successfully operative subjects in the experimental group or the control group. | within 24 hours after operation | |
Secondary | The breakage rate of gallbladder | The breakage rate of gallbladder is defined as the proportion of the subjects in the experimental group or the control group with specimen breakage. | within 12 hours after operation | |
Secondary | Comprehensive Complication Index (CCI) | CCI is calculated using online tools provided by http://cci.assessurgery.com. Based on the Clavien-Dindo complications grade system (appendix.1), all complications and adverse events after surgical intervention are taken into consideration. The overall incidence is measured on a scale ranging from 0 (no complication) to 100 (death). | an average of 5 days after operation | |
Secondary | Operative time | The length of time from the beginning of the operation after the robot installation to the end of the suture of the incision. | within 12 hours after operation | |
Secondary | Intraoperative bleeding | The total bleeding volume from the beginning of the operation to the end of the suture of the incision. It can be calculated by measuring the blood volume in the vacuum suction device and weighing the gauze after using them to wipe the bleeding. | within 12 hours after operation | |
Secondary | Postoperative pain | Postoperative pain is assessed by visual analogue scale (VAS) 24-26 hours after the operation, ranging from 0 (no pain) to 10 (maximum pain). | within 24 hours after operation | |
Secondary | Time to first flatus | The time from the end of the operation to the subject's first flatus after surgery. | an average of 2 days after operation | |
Secondary | Surgeon's satisfaction | After the operation, surgeons fill a questionnaire to score the flexibility, intuition and stability of the products, as well as their sense of delay and fatigue when using the products. Each question in the score ranges from 1 to 5 points and the total score is 100. | within 12 hours after operation | |
Secondary | Installation time | The time from the power-on of the products to the end of the connection between trocars and the operative arms. | preoperation | |
Secondary | Hospital stay | The total hospital days of subjects from admission to discharge. | an average of 5 days after operation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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