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The purpose of this study is to explore the clinical outcomes of the robotic distal gastrectomy for patients with gastric adenocarcinoma（cT1-4a, N-/+, M0）.
Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. The study is designed to explore the clinical outcomes of the robotic distal gastrectomy by comparing short- and long-term outcomes including financial cost of robotic and laparoscopic distal gastrectomy in the treatment of gastric adenocarcinoma （cT1-4a, N-/+, M0）.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Distal Gastrectomy | Experimental | Robotic Distal Gastrectomy will be performed for the treatment of patients assigned to this group. |
|
| Laparoscopic Distal Gastrectomy | Active Comparator | Laparoscopic Distal Gastrectomy will be performed for the treatment of patients assigned to this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Distal Gastrectomy | Procedure | After exclusion of T4b, bulky lymph nodes, or distant metastasis case, robotic distal gastrectomy will be performed in the experimental group. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free survival rate | the rate of 3-year disease free survival | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year overall survival rate | the rate of 3-year overall survival rate | 36 months |
| 3-year recurrence pattern | the pattern of recurrence in 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Changming Huang, Professor | Fujian Medical University Union Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37395806 | Derived | Lu J, Wu D, Huang JB, Lin J, Xu BB, Xue Z, Zheng HL, Lin GS, Shen LL, Li P, Wang JB, Lin JX, Chen QY, Cao LL, Xie JW, Zheng CH, Huang CM. Comparison of robotic versus laparoscopic versus open distal gastrectomy for locally advanced gastric cancer: a prospective trial-based economic evaluation. Surg Endosc. 2023 Oct;37(10):7472-7485. doi: 10.1007/s00464-023-10147-1. Epub 2023 Jul 3. |
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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 Distal Gastrectomy | Procedure | After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic distal gastrectomy will be performed in the comparator group. |
|
| 36 months |
| overall postoperative morbidity rates | Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery. | 30 days |
| 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 |
| number of retrieved lymph nodes | number of retrieved lymph nodes | 1 days |
| the noncompliance rate of lymphadenectomy | the noncompliance rate of lymphadenectomy | 1 days |
| Time to first ambulation | Time to first ambulation in hours is used to assess the postoperative recovery course. | 30 days |
| Time to first flatus | Time to first flatus in days is used to assess the postoperative recovery course. | 30 days |
| Time to first liquid diet | Time to first liquid diet in days is used to assess the postoperative recovery course. | 30 days |
| Time to first soft diet | Time to first soft diet in days is used to assess the postoperative recovery course. | 30 days |
| Duration of postoperative hospital stay | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. | 30 days |
| The variation of weight | The variation of weight in kilograms on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status. | 3, 6, 9 and 12 months |
| The variation of cholesterol | The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status. | 3, 6, 9 and 12 months |
| The variation of album | The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status. | 3, 6, 9 and 12 months |
| The variation of white blood cell count | The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 5 are recorded to access the inflammatory response. | Preoperative 7 days and postoperative 1 and 5 days |
| The variation of hemoglobin | The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 5 are recorded to access the inflammatory response. | Preoperative 7 days and postoperative 1 and 5 days |
| Hospitalization expenses | The cost from admission to discharge | 30 days |
| operation time | operation time | 1 days |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |