An interventional study of the MicroHand S endoscopic instrument control system and the da Vinci endoscopic instrument control system in Gallstone and Cholecystitis, sponsored by The Third Xiangya Hospital of Central South University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-25.
Sponsored by The Third Xiangya Hospital of Central South University · Not applicable, Interventional, and Treatment
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.
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.
266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.
This study's enrollment of 168 is above the median of 86 across 167 interventional studies indexed under Cholecystitis.
Browse Cholecystitis studies →The Third Xiangya Hospital of Central South University is the lead sponsor of 95 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
2 .American Society of Anesthesiologists (ASA): Level 1, Level 2 or Level 3
Exclusion Criteria:
MicroHand S robotic surgery group
Device: the MicroHand S endoscopic instrument control system
da Vinci robotic surgery group
Device: the da Vinci endoscopic instrument control system
Using the MicroHand S endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.
Using the da Vinci endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.
surgical success rate
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
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: preoperation
Hospital stay
The total hospital days of subjects from admission to discharge.
Time frame: an average of 5 days after operation
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The Third Xiangya Hospital of Central South University