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This [Study Type: Clinical Trial] aims to [Primary Objective: evaluate the long-term efficacy and safety of robotic gastrectomy for locally advanced gastric cancer] in [Participant Population: patients with locally advanced gastric cancer, aged >18 years and <75 years]. The primary questions it seeks to answer are:
Is the 3-year disease-free survival rate of robotic gastrectomy non-inferior to that of laparoscopic gastrectomy? Is the perioperative safety of robotic gastrectomy superior to that of laparoscopic gastrectomy? Researchers will compare [Intervention Groups: Robotic Gastrectomy vs. Laparoscopic Gastrectomy] to determine whether [robotic surgery offers advantages in long-term efficacy and perioperative safety].
Participants will:
Sign an informed consent form and be randomly assigned to either the robotic surgery group or the laparoscopic surgery group.
Undergo the assigned surgical procedure and receive regular follow-up visits (at 30 days, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 2 years, 2.5 years, and 3 years postoperatively).
Complete physical examinations, blood tests (including complete blood count, biochemical markers, and tumor markers), and imaging studies (such as abdominal CT, upper gastrointestinal endoscopy, and chest X-ray) during the follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Gastrectomy | Experimental |
| |
| Laparoscopic Gastrectomy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Gastrectomy | Procedure | The intervention measures for robotic gastrectomy include: Preoperative Preparation: Comprehensive preoperative examinations, including imaging studies, laboratory tests, and tumor marker assessments, to confirm the diagnosis and staging. Surgical Procedure: Utilizing the da Vinci Surgical System, which provides a high-definition 3D view and flexible robotic arms for enhanced surgical precision. Lymphadenectomy: Systematic D2 lymph node dissection according to oncological standards to ensure thorough removal of regional lymph nodes. Gastrectomy and Reconstruction: Performing subtotal or total gastrectomy based on tumor location and extent, with intracorporeal reconstruction assisted by the robotic system. Postoperative Management: Close monitoring of vital signs, pain management, and early mobilization to facilitate recovery, along with prevention and management of postoperative complications. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease-free survival rate | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall postoperative complication rate | 3 years | |
| Intraoperative complication rate | 3 years | |
| Overall postoperative complication rate of Clavien-Dindo Grade II or higher |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Shi | Contact | 13752909448 | shiyandoctor@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Southwest hospital of AMU | Not yet recruiting | Chongqing | Chongqing Municipality | 400038 | 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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|
| Laparoscopic Gastrectomy | Procedure | Preoperative Preparation: Confirm diagnosis and staging through imaging and laboratory tests. Surgical Procedure: Use standard laparoscopic instruments and 2D HD camera. Lymphadenectomy: Perform systematic D2 lymph node dissection. Gastrectomy and Reconstruction: Conduct subtotal or total gastrectomy and intracorporeal reconstruction. Postoperative Management: Monitor vital signs, manage pain, and promote early mobilization. |
|
| 3 years |
| 3-year OS rate | 3 years |
| The Southwest hospital of AMU | Recruiting | Chongqing | Chongqing Municipality | 400038 | China |
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |