A Clinical Study of Chinese Domestic Surgical Robot
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|ClinicalTrials.gov Identifier: NCT04122261|
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gallstone Cholecystitis||Device: the MicroHand S endoscopic instrument control system Device: the da Vinci endoscopic instrument control system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Study Start Date :||October 13, 2019|
|Estimated Primary Completion Date :||October 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
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.
- surgical success rate [ Time Frame: 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.
- The breakage rate of gallbladder [ Time Frame: 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) [ Time Frame: 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).
- Operative time [ Time Frame: 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 [ Time Frame: 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.
- Postoperative pain [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Installation time [ Time Frame: preoperation ]The time from the power-on of the products to the end of the connection between trocars and the operative arms.
- Hospital stay [ Time Frame: an average of 5 days after operation ]The total hospital days of subjects from admission to discharge.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122261
|Contact: Shaihong Zhu, M.D.||+86 email@example.com|
|The Third Xiangya Hospital of Central South University||Recruiting|
|Changsha, Hunan, China, 410013|
|Contact: Shaihong Zhu, M.D. +86 15974267868 firstname.lastname@example.org|
|Principal Investigator: Shaihong Zhu, M.D.|
|Sub-Investigator: Guohui Wang, M.D.|
|Principal Investigator:||Shaihong Zhu, M.D.||The Third Xiangya Hospital of Central South University|