A Clinical Study of Chinese Domestic Surgical Robot

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

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.

Study Overview

• Status: Completed
• Conditions: Cholecystitis; Gallstone
• Intervention / Treatment: Device: the MicroHand S endoscopic instrument control system; Device: the da Vinci endoscopic instrument control system

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 Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Third Xiangya Hospital of Central South University
• Collaborators: The Affiliated Hospital of Qingdao University

Publications and helpful links

General Publications

• Wang G, Yi B, Li Z, Zhu L, Hao L, Zeng Y, Zhu S. Micro-Hand Robot-Assisted Versus da Vinci Robot-Assisted Cholecystectomy: A Multi-centre, Randomized Controlled Trial. World J Surg. 2022 Nov;46(11):2632-2641. doi: 10.1007/s00268-022-06668-w. Epub 2022 Jul 20.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2019
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: September 28, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Cholelithiasis; Cholecystolithiasis; Cholecystitis; Gallstones
• Other Study ID Numbers: SDWG-NST600S-CT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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