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This is a randomized controlled trial that will be preceded by a safety trial focusing on the safety and efficacy of robotic telesurgery. The hypothesis is that robotic telesurgery has a non-inferior primary endpoint event rate to local laparoscopic surgery.
First, a safety run-in trial for robotic telesurgery will be conducted and evaluated according to "3+3 design". At least 3 patients of each cancer type (including liver cancer,renal cancer and rectal cancer) will be enrolled for robotic telesurgery. If there is a tumor type for which the prior safety trial is terminated, the subsequent randomized controlled trial will not include patients of that type.
Second, after passing the safety run-in trial, a randomized controlled trial will be performed. New patients with each cancer type who met the enrollment criteria will be randomly assigned to either the laparoscopic surgery group(control group) or the robotic telesurgery group (intervention group) (84 patients in each group, 168 patients in total) in a 1:1 two-group parallel design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic telesurgery | Experimental | Patients with liver cancer, renal cancer, rectal cancer will be treated by telesurgery. |
|
| Laparoscopic surgery | Active Comparator | Patients with liver cancer, renal cancer, rectal cancer will be treated by laparoscopic surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic telesurgery | Procedure | Telesurgery by domestic surgical robot |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical complication | Overall complication events within 30 days of surgery or intraoperative emergency intermediate open surgery events as defined by the Clavin-Dindo grading system | One month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical time (min) | Total time from the start of surgery after robotic or laparoscopic installation to the end of incision closure and the surgeon's operating time. | One month after surgery |
| Intraoperative blood loss (mL) |
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Inclusion Criteria:
Liver Cancer:
Renal cancer:
Rectal cancer:
Exclusion Criteria:
Liver Cancer:
Renal cancer:
Rectal cancer:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kuang Ming, PhD | Contact | 008687755766 | 8576 | kuangm@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Kuang Ming, PhD | First Affiliated Hospital of Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D007680 | Kidney Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Laparoscopic surgery |
| Procedure |
Local laparoscopic surgery |
|
Total bleeding from the start of surgery to the end of incision suturing.
| One month after surgery |
| Postoperative hospitalization days | Number of days from the day of surgery to the day of discharge. | One month after surgery |
| Physician satisfaction | A NASA-TLX quantification form was completed by the physician postoperatively. | One month after surgery |
| Remote metrics | Record data related to network transmission end-to-end latency time, jitter, and frame loss. | One month after surgery |
| D008107 |
| Liver Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |