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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 ingynaecological surgical procedures.
The trial was designed using a prospective, single-centre, single-group target value approach.
For subjects who intend to undergo gynaecological 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 , and to evaluate the efficacy and safety of the experimental medical device in the surgical treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-assisted surgery | Experimental | Robot-assisted laparoscopic wide total hysterectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted surgery | Device | 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 |
| Intraoperative blood loss | Estimated blood loss（milliliters，ml） |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JiangTao Fan, MD | First Affiliated Hospital of Guangxi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornerstone Robotics | Shenzhen | Guangdong | 518000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28528932 | Background | Tse KY, Ngan HYS, Lim PC. Robot-assisted gynaecological cancer surgery-complications and prevention. Best Pract Res Clin Obstet Gynaecol. 2017 Nov;45:94-106. doi: 10.1016/j.bpobgyn.2017.04.005. Epub 2017 Apr 23. | |
| 21974854 | Background | Pugin F, Bucher P, Morel P. History of robotic surgery: from AESOP(R) and ZEUS(R) to da Vinci(R). J Visc Surg. 2011 Oct;148(5 Suppl):e3-8. doi: 10.1016/j.jviscsurg.2011.04.007. Epub 2011 Oct 4. No abstract available. |
| Label | URL |
|---|---|
| Ever since the US Food and Drug Administration approval of the use of da Vinci surgical systems (Intuitive Surgical Inc., Sunnyvale, California) in gynaecology in 2005, robot-assisted surgery has been widely adopted in different countries. | View source |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
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| During the surgery |
| Length of postoperative stay | Total number of days the patient was in hospital from the day of surgery to discharge. | up to 12 weeks |
| History of robotic surgery: from AESOP® and ZEUS® to da Vinci® | View source |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D013672 |
| Technology |
| D013676 | Technology, Industry, and Agriculture |