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The purpose of this study is to explore the clinical efficacy between robotic and laparoscopic total gastrectomy in patients with clinical Stage I gastric cancer
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 assisted total gastrectomy by comparing short- and long-term outcomes including financial cost of robotic and laparoscopic assisted total gastrectomy in the treatment of clinical Stage I gastric adenocarcinoma （cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0））.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Assisted Total Gastrectomy | Experimental | Robotic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group. |
|
| Laparoscopic Assisted Total Gastrectomy | Active Comparator | Laparoscopic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Assisted Total Gastrectomy | Procedure | After exclusion of T4b, bulky lymph nodes, or distant metastasis case,robotic assisted total 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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Changming Huang, Professor | Contact | +86-138-0506-9676 | hcmlr2002@163.com | |
| Mi Lin, M.D. | Contact | +86-134-5915-2658 | 170894572@qq.com |
| 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 | Recruiting | Fuzhou | Fujian | 350000 | China |
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| Laparoscopic Assisted Total Gastrectomy | Procedure | After exclusion of T4b, bulky lymph nodes, or distant metastasis case,laparoscopic assisted total gastrectomy will be performed in the experimental 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 |
| 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 white blood cell count | The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory response. | Preoperative 3 days and postoperative 1, 3, and 5 days |
| Hospitalization expenses | The cost from admission to discharge | 30 days |
| operation time | operation time | 1 day |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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