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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
All the surgical procedures are performed using the robot system.
After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Morbidity rates
This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.
Time frame: 30 days
3-year disease free survival rate
3-year disease free survival rate
Time frame: 36 months
3-year overall survival rate
3-year overall survival rate
Time frame: 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.
Time frame: 36 months
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
Total Number of Retrieved Lymph Nodes
Total Number of Retrieved Lymph Nodes
Time frame: 1 day
postoperative recovery course
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time frame: 30 days
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postoperative nutritional status
The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.
Time frame: 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
Time frame: 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
Time frame: 1 day