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Evaluation of the efficacy and safety of thoracic and abdominal endoscopic surgical systems manufactured by Shenzhen Cornerstone Robotics Technology Co., Ltd. for use in general, gynaecological and thoracic surgical procedures.
The trial was designed using a prospective, multi-centre, single-group target value approach.
For subjects who intend to undergo general surgery, gynaecological surgery and thoracic surgery assisted by the Thoracic and Abdominal Endoscopic Surgical System.
To use the Thoracic and Abdominal Endoscopic Surgical System developed by Shenzhen Cornerstone Robotics Technology Co., Ltd. to perform surgery in the above three disciplines, and to evaluate the efficacy and safety of the experimental medical device in the surgical treatment of the above three disciplines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-assisted surgery | Experimental | Robot-assisted thoraco-laparoscopic esophagectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted surgery | Procedure | Surgery with the Cornerstone Surgical Robot. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical non-referral rate | Surgical untransferred is defined as not converted from an experimental medical device assisted method to another surgical device control system assisted, laparoscopic surgery or open surgery. | during the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The surgeon's operating time | Operative time（minutes） | during the surgery |
| Length of postoperative stay | Total number of days the patient was in hospital from the day of surgery to discharge. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiujun Cai, MD | President of Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25670040 | Background | Park JY, Ryu KW, Reim D, Eom BW, Yoon HM, Rho JY, Choi IJ, Kim YW. Robot-assisted gastrectomy for early gastric cancer: is it beneficial in viscerally obese patients compared to laparoscopic gastrectomy? World J Surg. 2015 Jul;39(7):1789-97. doi: 10.1007/s00268-015-2998-4. | |
| 33299282 | Background | Somashekhar SP, Deshpande AY, Ashwin KR, Gangasani R, Kumar R, Shetty S. Comparative Evaluation of the Short-Term Treatment Outcomes Between Open, Laparoscopic- and Robotic-Assisted Surgical Approaches for Rectal Cancer Treatment. Indian J Surg Oncol. 2020 Dec;11(4):649-652. doi: 10.1007/s13193-020-01137-z. Epub 2020 Jul 10. |
| Label | URL |
|---|---|
| The adoption of robotic systems for gastric cancer surgery has been proven feasible and safe; however, a benefit over the laparoscopic approach has not yet been well-documented. | View source |
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| up to 12 weeks |
| Intraoperative blood loss | Estimated blood loss（milliliters，ml） | during the surgery |
| Length of stay | The postoperative day when patients complied with the predefined discharge criteria | The patient's total number of days from the day of surgery to discharge was recorded 30 days postoperatively. |
| The open surgeries and more recently minimal invasive surgeries aided by laparoscopic or robotic approaches are employed for rectal cancer treatment procedures. | View source |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
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| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
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