A Clinical Study of Chinese Domestic Surgical Robot

Not Applicable

Completed

• Conditions: Cholecystitis; Gallstone
• Interventions: Device: the da Vinci endoscopic instrument control system; Device: the MicroHand S endoscopic instrument control system

• Registration Number: NCT04122261
• Lead Sponsor: The Third Xiangya Hospital of Central South University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-09-28
• Study First Submitted QC: 2019-10-09
• Study First Posted: 2019-10-10
• Study Start: 2019-10-13
• Primary Completion: 2020-10-01
• Status Verified: 2021-10
• Study Completion: 2021-10-01
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	the da Vinci endoscopic instrument control system	da Vinci robotic surgery group
experimental group	the MicroHand S endoscopic instrument control system	MicroHand S robotic surgery group

Primary Outcome Measures

Name	Time	Method
surgical success rate	within 24 hours after operation	The surgical success rate is defined as the proportion of successfully operative subjects in the experimental group or the control group.

Secondary Outcome Measures

Name	Time	Method
Operative time	within 12 hours after operation	The length of time from the beginning of the operation after the robot installation to the end of the suture of the incision.
Intraoperative bleeding	within 12 hours after operation	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.
Installation time	preoperation	The time from the power-on of the products to the end of the connection between trocars and the operative arms.
The breakage rate of gallbladder	within 12 hours after operation	The breakage rate of gallbladder is defined as the proportion of the subjects in the experimental group or the control group with specimen breakage.
Comprehensive Complication Index (CCI)	an average of 5 days after operation	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).
Postoperative pain	within 24 hours after operation	Postoperative pain is assessed by visual analogue scale (VAS) 24-26 hours after the operation, ranging from 0 (no pain) to 10 (maximum pain).
Time to first flatus	an average of 2 days after operation	The time from the end of the operation to the subject's first flatus after surgery.
Surgeon's satisfaction	within 12 hours after operation	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.
Hospital stay	an average of 5 days after operation	The total hospital days of subjects from admission to discharge.

Trial Locations

Locations (1)

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China