Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to explore clinical outcomes of totally laparoscopic versus laparoscopy assisted total gastrectomy for gastric cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Totally Laparoscopic Total Gastrectomy | Experimental | Totally Laparoscopic Total Gastrectomy will be performed for the treatment of patients assigned to this group. |
|
| Laparoscopy Assisted Total Gastrectomy | Experimental | Laparoscopy Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Totally Laparoscopic Total Gastrectomy | Procedure | After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Totally Laparoscopic Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year overall survival rate | 36 months | |
| 3-year disease free survival rate | 36 months | |
| 3-year recurrence pattern |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Changming Huang, Professor | Fujian Medical University Union Hospital,China | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Laparoscopy Assisted Total Gastrectomy | Procedure | After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Laparoscopy Assisted Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience. |
|
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 |
| 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 |
| Postoperative pain | Visual analog pain score method is used to evaluate the difference of postoperative pain degree.The score of postoperative pain is used to assess the postoperative recovery course. | 30 days |
| The variation of weight | The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life. | 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 and quality of life. | 3, 6, 9 and 12 months |
| The results of endoscopy | The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life. | 3 and 12 months |
| The variation of body temperature | The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response. | 8 days |
| 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 and immune response. | Preoperative 3 days and postoperative 1, 3, and 5 days |
| The variation of hemoglobin | The values of hemoglobin in gram/liter 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 |
| The variation of C-reactive protein | The values of C-reactive protein IN milligram/liter 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 |
| 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 |
Not provided
Not provided