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| Name | Class |
|---|---|
| The Affiliated Hospital of Qingdao University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | MicroHand S robotic surgery group |
|
| control group | Experimental | da Vinci robotic surgery group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the MicroHand S endoscopic instrument control system | Device | Using the MicroHand S endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery. |
| 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 |
| 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) |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Shaihong Zhu, M.D. | The Third Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35857076 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 1, 2019 | Oct 5, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2019 | Oct 5, 2019 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D042882 | Gallstones |
| D002764 | Cholecystitis |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
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| the da Vinci endoscopic instrument control system | Device | Using the da Vinci endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery. |
|
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 |
| D005705 |
| Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |