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This clinical study was a prospective, single-center, single-arm exploratory study. Subjects who meet the inclusion criteria will be enrolled in this study, where surgeons will perform single-port robot-assisted gastrectomy, and explore and evaluate the safety and efficacy of this clinical application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-port robot-assisted gastrectomy | Experimental | SHURUI Endoscopic Surgical Robotic System (SR-ENS-600) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHURUI Endoscopic Surgical Robotic System (SR-ENS-600) | Device | SHURUI Endoscopic Surgical Robotic System (SR-ENS-600) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of intraoperative complications | Intraoperative complications, including organ injury and vascular injury, were evaluated | The day of surgery |
| The rate of postoperative complications | Postoperative complications, including postoperative bleeding, fever, and incisional infection, were evaluated using the Clavien-Dindo grading system to determine whether the occurrence of complications was related to the study instrument or surgery. | Postoperative 30 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative system failure rate | The day of surgery | |
| Surgical completion rate | The day of surgery | |
| Intraoperative blood loss |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan Tian | Contact | 800-555-5555 | tangy0767@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General Surgery | Shijiazhuang | Hebei | 050011 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| The day of surgery |
| Operation time | The day of surgery |
| Preoperative device assembly time | The day of surgery |
| Intraoperative instrument operation error rate | The day of surgery |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |