| Background:Gastric cancer is the sixth most common and the third most deadly malignant tumor in the world.Radical gastrectomy can greatly increase the survival rate of patients with gastric cancer.In recent years,with the development of minimally invasive technology,laparoscopic radical gastrectomy for gastric cancer has been widely recognized in terms of safety and effectiveness.However,it is uncertain whether robot-assisted total gastrectomy can improve the clinical outcome of patients with gastric cancer.We adopt a prospective,randomized and controlled approach,To statistically analyze the clinical data of patients undergoing robotic and laparoscopic assisted total gastrectomy in our center in the same period,we will conduct a high-quality RCT study according to the CONSORT statement to observe the recent clinical outcome indicators of patients undergoing robotic and laparoscopic total gastrectomy,and explore the safety and feasibility of robotic surgery.Methods:This study is a single-center,prospective,randomized,controlled trial.The patients with gastric cancer admitted by the Department of Gastroenterology of the Affiliated Hospital of Qingdao University from September 2020 to September 2022 and those who underwent laparoscopic or robotic radical total gastrectomy were randomly divided into two groups: robotic radical total gastrectomy group and laparoscopic radical total gastrectomy group.Inclusion criteria:(1)The age of the patient is 18-80 years old,regardless of gender.(2)According to the fifth edition of the Japanese guidelines for the treatment of gastric cancer,patients undergoing total gastrectomy.(3)Patients with gastric adenocarcinoma diagnosed by endoscopic biopsy of digestive tract.(4)Patients with preoperative clinical staging of c T2-4a,N0/+,M0(adjusted according to the 8th edition of the United States Joint Commission on Cancer(AJCC)staging system).(5)Patients with KPS score ≥ 60 or ECOG score ≤ 2.(6)Patients with ASA grade ≤ 3.(7)The patients and their families signed informed consent.Exclusion criteria:(1)Patients who have previously undergone gastrectomy,endoscopic mucosal resection of the digestive tract or endoscopic submucosal dissection of the digestive tract.(2)Patients who have had other malignant diseases in the past five years.(3)Patients with heart,lung,liver and kidney insufficiency or a history of cerebral infarction.(4)Patients who have to undergo emergency surgery due to complications of gastric cancer(bleeding,obstruction or perforation).(5)The patient who plans to undergo minimally invasive surgery but eventually changes to open surgery due to various factors.(6)Patients who have previously undergone upper abdominal surgery(except for laparoscopic cholecystectomy).Exit criteria:(1)No evidence of distant metastasis was found in preoperative examination,but patients with distant metastasis were confirmed by intraoperative exploration/postoperative pathological examination.(2)Patients who were proved unable to complete D2 lymph node dissection/R0 resection due to tumor during operation.(3)Patients who have other diseases that require surgical treatment at the same time.(4)Patients who voluntarily request to withdraw from the study or discontinue treatment due to personal reasons rather than curative effects.The two groups of patients were managed according to the ERAS perioperative management plan,and all treatment measures were the same except for the surgical method.During this period,a total of 86 patients with gastric cancer who met the standard of nanofiltration were randomly assigned to the robot group and the laparoscopic group.Finally,40 patients in the robot group and 42 patients in the laparoscopic group were included in this study.MAIN OUTCOME MEASURES: Postoperative complications(incision infection,respiratory infection,pleural effusion,abdominal bleeding,abdominal infection,gastrointestinal obstruction,anastomotic leakage,pancreatic leakage,thromboembolism,etc.),Clavein-Dindo grade,number of errors in operation.Secondary outcome measures: total operation time,operation time under pneumoperitoneum,operation bleeding volume,blood transfusion rate,pathological examination results of cutting edge,postoperative fever time and days,postoperative drainage tube removal time,postoperative exhaust and defecation time,fluid diet time,postoperative hospitalization time,postoperative blood transfusion,total hospitalization cost,re-admission rate within 30 days,unplanned re-operation rate Laboratory data(various hematological indexes before and 1.3.5 days after operation),and the interval between patients in each group receiving adjuvant chemotherapy after operation.Results:The statistical analysis showed that the baseline data between the two groups had no statistical difference,while the estimated intraoperative blood loss in the robot group was lower(80.51 ± 68.77 vs 89.89 ± 66.12,P=0.008),and the total number of lymph node dissection was higher(34.74 ± 12.44 vs 29.83 ± 12.22,P<0.001)compared with the LTG group.The number of lymph node dissection at the upper edge of pancreas in RTG group was more than that in LTG group(12.59 ± 4.18 vs 10.33 ± 4.58,P=0.001).In addition,the postoperative recovery indexes and some laboratory data of the RTG group were better than those of the LTG group,while the postoperative complications of the two groups were not significantly different(19.0% vs 18.9%,P=0.962),and the number of surgical errors in the RTG group was significantly lower than that in the LTG group.Conclusions:The RTG group showed better intraoperative performance,which can improve the short-term clinical results of patients,and is more conducive to the rehabilitation of patients.There was no statistical difference in the incidence of postoperative complications between the two groups.The number of operational errors in the RTG group was lower than that in the LTG group,and the safety of robot surgery was guaranteed.In addition,the robot surgery system can reduce the surgical stress reaction of patients and enable them to receive postoperative chemotherapy more quickly.However,the cost of surgery for robot group is higher,which is the main factor restricting its wide application. |
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