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）.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
After exclusion of T4b, bulky lymph nodes, or distant metastasis case, robotic distal gastrectomy will be performed in the experimental group.
After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic distal gastrectomy will be performed in the comparator group.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
3-year disease free survival rate
the rate of 3-year disease free survival
Time frame: 36 months
3-year overall survival rate
the rate of 3-year overall survival rate
Time frame: 36 months
3-year recurrence pattern
the pattern of recurrence in 3 years
Time frame: 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.
Time frame: 30 days
intraoperative morbidity rates
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Time frame: 1 day
overall postoperative serious morbidity rates
Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher
Time frame: 30 days
number of retrieved lymph nodes
number of retrieved lymph nodes
Time frame: 1 days
the noncompliance rate of lymphadenectomy
the noncompliance rate of lymphadenectomy
Time frame: 1 days
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Time to first ambulation
Time to first ambulation in hours is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first flatus
Time to first flatus in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first liquid diet
Time to first liquid diet in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first soft diet
Time to first soft diet in days is used to assess the postoperative recovery course.
Time frame: 30 days
Duration of postoperative hospital stay
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Preoperative 7 days and postoperative 1 and 5 days
Hospitalization expenses
The cost from admission to discharge
Time frame: 30 days
operation time
operation time
Time frame: 1 days