A Real World Study of the Effect of Laparoscopic Preservation of the Pylorus and Vagus Nerve on the Postoperative Quality of Life in Patients With Early Gastric Cancer

The overall design of this study is an experimental study based on the real world. All the patients in the study group were from early gastric cancer patients who were operated on in gastrointestinal surgery of Renji Hospital. According to the preoperative evaluation of early gastric cancer (gastroscope, ultrasonic gastroscope and abdominal enhanced CT), patients with early gastric cancer whose tumor is located in the gastric body and whose cutting edge is enough to retain pylorus and non lymph node metastasis (N0) were included in the study. Group A (Study Group): lappg treatment group, group B (control group): laparoscopic distal gastrectomy type I group. In this study, group A was taken as the study group and group B as the control group Group, the differences between groups were compared. The main end point was the quality of life score (eortc-qlq-c30 scale, see the attached table). According to the literature and the data of the retrospective study of the center, it was assumed that the expected mean of the study group after treatment was 7.27, the mean of the control group after treatment was 6.76, and the total standard deviation of the test group and the control group was 0.51. The design of the test group and the control group was 1:1. According to this, two independent α = 0.05 were carried out Test of the average number of standing samples. It is calculated that 144 patients (72 in each group) are needed, so that under the test level of α = 0.05, according to 80% test efficiency, the difference between the two groups is statistically significant. Assuming that 10% of the patients could not be evaluated (shedding), 80 patients in each group were enrolled, and 160 patients in both groups were enrolled.

2. inclusion / exclusion / withdrawal criteria of subjects

Inclusion criteria: 18 years old < age < 75 years old; primary gastric lesions were diagnosed as gastric adenocarcinoma by tissue biopsy; preoperative clinical stage was T1N0M0 according to ajcc-7thtnm tumor stage; the tumor site was expected to receive R0 after pylorus preserving gastrectomy and D1 + lymph node dissection; preoperative Eastern Cooperative Oncology Group physical state score was 0 / 1; preoperative ASA score was I-III, with informed consent of the patient.

Exclusion criteria: pregnant or lactating women; severe mental illness; history of upper abdominal surgery (except for laparoscopic cholecystectomy); history of gastric surgery (including endoscopic submucosal dissection/ endoscopic mucosal resection for gastric cancer); preoperative imaging examination showed regional enlarged lymph nodes; history of other malignant diseases within 5 years; patients with gastric cancer who have implemented new adjuvant treatment or recommended new adjuvant treatment; no History of stable angina pectoris or myocardial infarction; history of cerebral infarction or cerebral hemorrhage within 6 months; history of continuous systemic corticosteroid therapy within 1 month; simultaneous operation for other diseases; emergency operation for gastric cancer with complications (hemorrhage, perforation, obstruction).

Withdrawal criteria: conversion to laparotomy; intraoperative / postoperative pathological confirmation of tumor invasion depth exceeding T1, or tumor invasion of duodenum; intraoperative / postoperative pathological confirmation of lymph node metastasis; intraoperative / postoperative pathological confirmation of M1 cases; intraoperative confirmation of failure to complete D1 + lymph node dissection / R0 due to tumor reasons; intraoperative confirmation of the need for total gastrectomy to ensure safe proximity; need for other diseases During the same period of the study, the patients were operated at the same time; because of severe complications (unable to tolerate surgery or anesthesia) during the perioperative period, the treatment plan of the study was not suitable or could not be implemented according to the plan; after entering the study, because of the patient's condition change, the emergency operation was confirmed by the doctor in charge; at any stage after entering the study, the patients voluntarily requested to withdraw or suspend the treatment due to the patient's personal reasons Treatment; treatment proven to be in violation of this protocol.