A Clinical Study of Chinese Domestic Surgical Robot

Study Overview
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Brief Summary
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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.

Detailed Description
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To evaluate the safety and efficacy of the Chinese domestic endoscopic instrument control system in clinical treatment.This clinical trial is a prospective, multi-center, randomized, single-blind, parallel-controlled study. The system used in the experimental group is the endoscopic instrument control system developed by WEGO Surgical Robot Co., Ltd., and the system used in the control group is the da Vinci endoscopic instrument control system developed by Intuitive Surgical. Before patients are enrolled in this clinical study, the researchers will do a detailed screening of the subjects based on the inclusion criteria and the exclusion criteria to determine if the patients are appropriate for the clinical study. Patients who meet the conditions of the study will be required to sign an informed consent form. Then they will be randomly assigned to the experimental group or the control group. To evaluate the primary outcome measures and secondary outcome measures and to observe the incidence of organ and vascular injury. Finally, we evaluate the safety and efficacy of the test product through the comparison of the data obtained from the experimental group and the control group during the treatment.

Official Title
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Prospective, Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trial Protocol for the Safety and Efficacy of Clinical Applications of the Endoscopic Instrument Control System

Conditions
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Gallstone, Cholecystitis

Intervention / Treatment
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* Device: the MicroHand S endoscopic instrument control system
* Device: the da Vinci endoscopic instrument control system


Participation Criteria
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Eligibility Criteria
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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: Participating in any other clinical trial within 30 days before signing the informed consent form Pregnancy or lactation With a history of epilepsy or psychosis With a history of previous operations at related sites Severe cardiovascular and cerebrovascular diseases with New York grade III-IV cardiac function or pulmonary insufficiency that can't tolerate the operation Severe liver and kidney insufficiency such as cirrhosis and renal failure 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 Acute cholangitis, gallstone with acute pancreatitis, primary common bile duct stones, intrahepatic bile duct stones and obstructive jaundice Gallbladder cancer or protuberant lesions are suspected to be cancerous Severe allergic constitution and suspected or identified addicts to alcohol or drugs Abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastatic diseases Other situations that researchers consider it inappropriate to participate in this clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>MicroHand S robotic surgery group | Device: the MicroHand S endoscopic instrument control system<br>* Using the MicroHand S endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.<br>|
| Experimental: control group<br>da Vinci robotic surgery group | Device: the da Vinci endoscopic instrument control system<br>* Using the da Vinci endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Installation time | The time from the power-on of the products to the end of the connection between trocars and the operative arms. | preoperation | 
| Hospital stay | The total hospital days of subjects from admission to discharge. | an average of 5 days after operation |