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)).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
After exclusion of T4b, bulky lymph nodes, or distant metastasis case,robotic assisted total gastrectomy will be performed in the experimental group.
After exclusion of T4b, bulky lymph nodes, or distant metastasis case,laparoscopic assisted total gastrectomy will be performed in the experimental group.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITING3-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
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
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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 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.
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
Hospitalization expenses
The cost from admission to discharge
Time frame: 30 days
operation time
operation time
Time frame: 1 day