A Clinical Study of Chinese Domestic Surgical Robot
Primary Purpose
Gallstone, Cholecystitis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the MicroHand S endoscopic instrument control system
the da Vinci endoscopic instrument control system
Sponsored by
About this trial
This is an interventional treatment trial for Gallstone
Eligibility Criteria
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
Sites / Locations
- The Third Xiangya Hospital of Central South University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
experimental group
control group
Arm Description
MicroHand S robotic surgery group
da Vinci robotic surgery group
Outcomes
Primary Outcome Measures
surgical success rate
The surgical success rate is defined as the proportion of successfully operative subjects in the experimental group or the control group.
Secondary Outcome Measures
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.
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).
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.
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.
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).
Time to first flatus
The time from the end of the operation to the subject's first flatus after surgery.
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.
Installation time
The time from the power-on of the products to the end of the connection between trocars and the operative arms.
Hospital stay
The total hospital days of subjects from admission to discharge.
Full Information
NCT ID
NCT04122261
First Posted
September 28, 2019
Last Updated
October 21, 2021
Sponsor
The Third Xiangya Hospital of Central South University
Collaborators
The Affiliated Hospital of Qingdao University
1. Study Identification
Unique Protocol Identification Number
NCT04122261
Brief Title
A Clinical Study of Chinese Domestic Surgical Robot
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 13, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Third Xiangya Hospital of Central South University
Collaborators
The Affiliated Hospital of Qingdao University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstone, Cholecystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
MicroHand S robotic surgery group
Arm Title
control group
Arm Type
Experimental
Arm Description
da Vinci robotic surgery group
Intervention Type
Device
Intervention Name(s)
the MicroHand S endoscopic instrument control system
Intervention Description
Using the MicroHand S endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.
Intervention Type
Device
Intervention Name(s)
the da Vinci endoscopic instrument control system
Intervention Description
Using the da Vinci endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.
Primary Outcome Measure Information:
Title
surgical success rate
Description
The surgical success rate is defined as the proportion of successfully operative subjects in the experimental group or the control group.
Time Frame
within 24 hours after operation
Secondary Outcome Measure Information:
Title
The breakage rate of gallbladder
Description
The breakage rate of gallbladder is defined as the proportion of the subjects in the experimental group or the control group with specimen breakage.
Time Frame
within 12 hours after operation
Title
Comprehensive Complication Index (CCI)
Description
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).
Time Frame
an average of 5 days after operation
Title
Operative time
Description
The length of time from the beginning of the operation after the robot installation to the end of the suture of the incision.
Time Frame
within 12 hours after operation
Title
Intraoperative bleeding
Description
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.
Time Frame
within 12 hours after operation
Title
Postoperative pain
Description
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 Frame
within 24 hours after operation
Title
Time to first flatus
Description
The time from the end of the operation to the subject's first flatus after surgery.
Time Frame
an average of 2 days after operation
Title
Surgeon's satisfaction
Description
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.
Time Frame
within 12 hours after operation
Title
Installation time
Description
The time from the power-on of the products to the end of the connection between trocars and the operative arms.
Time Frame
preoperation
Title
Hospital stay
Description
The total hospital days of subjects from admission to discharge.
Time Frame
an average of 5 days after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaihong Zhu, M.D.
Organizational Affiliation
The Third Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35857076
Citation
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.
Results Reference
derived
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A Clinical Study of Chinese Domestic Surgical Robot
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