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To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of total robotic versus robotic assisted distal gastrectomy for patients with gastric cancer (cT1-4a, N0/+, M0).
In the field of gastrectomy, Hashizume et al. first reported robotic gastrectomy in 2002. Since then, reports on the safety and feasibility of the application of robotic surgical system in the treatment of gastric cancer (GC) have gradually increased. Reports of robotic surgery for GC are increasing, especially in Asia. Several studies confirmed the advantages of robotic gastrectomy when compared with laparoscopic gastrectomy. However, whether total robotic gastrectomy is noninferior to robotic-assisted gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of total robotic versus robotic assisted distal gastrectomy for GC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Robotic Distal Gastrectomy | Experimental | After exploration and randomization, patients received total robotic distal gastrectomy |
|
| Robotic-Assisted Distal Gastrectomy | Active Comparator | After exploration and randomization, patients received robotic-assisted distal gastrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Robotic Distal Gastrectomy | Procedure | All the surgical procedures are performed using the robot system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity rates | This is for the early postoperative complication, which defined as the event observed within 30 days after surgery. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free survival rate | 3-year disease free survival rate | 36 months |
| 3-year overall survival rate | 3-year overall survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang-ming Huang, MD | Contact | +86-13805069676 | hcmlr2002@163.com | |
| Qi-yue Chen, PhD | Contact | +86-15980235636 | 690934662@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Chang-ming Huang, MD | Fujian Medical University Union Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | 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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| Robotic-Assisted Distal Gastrectomy | Procedure | After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal. |
|
| 36 months |
| 3-year recurrence pattern | Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type. | 36 months |
| intraoperative morbidity rates | The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. | 1 day |
| overall postoperative serious morbidity rates | Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher | 30 days |
| Total Number of Retrieved Lymph Nodes | Total Number of Retrieved Lymph Nodes | 1 day |
| postoperative recovery course | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. | 30 days |
| postoperative nutritional status | The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status. | 3, 6, 9 and 12 months |
| inflammatory immune response | The variation of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response | Preoperative 3 days and postoperative 1, 3, and 5 days |
| Time of digestive tract reconstruction | From the beginning to the end of digestive tract reconstruction | 1 day |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |