A Single-center, Randomized, Controlled Clinical Study of the Effects of Modified and Traditional BII+Braun Digestive Tract Reconstruction Methods on Quality of Life After Radical Gastrectomy for Distal Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 592
- 试验地点
- 1
- 主要终点
- Effects of quality of life
研究概览
简要总结
The jejunum of the input segment is properly ligated with double line 7 at 3-5cm from the anastomotic site, and the jejunum of the output segment is extended to 30cm
详细描述
The T1-4a N0-3 M0 gastric adenocarcinoma patients were used to evaluate whether the quality of life after modified BII+Braun digestive tract reconstruction was superior to the traditional BII+Braun digestive tract reconstruction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18<age<75
- •Gastric lesions were diagnosed as gastric adenocarcinoma by endoscopic biopsy
- •The preoperative clinical stage is T1-4a,N0-3,M0(According to AJCC- 7th TNM tumor stage)
- •It is expected that the results of R0 surgery can be obtained by performing distal gastrectomy and D2 lymph node dissection
- •Preoperative ECOG performance status score 0/1
- •Nutrition risk screening（NRS2002）
- •Preoperative ASA score I-III
- •Patient informed consent
排除标准
- •Pregnancy or breastfeeding women
- •Severe mental illness
- •History of upper abdominal surgery
- •History of gastric surgery (including ESD/EMR for gastric cancer)
- •3 years of history of other malignant diseases；
- •Gastric cancer patients who have undergone neoadjuvant treatment or recommend neoadjuvant treatment
- •A history of unstable angina or myocardial infarction within 6 months
- •History of cerebral infarction or cerebral hemorrhage within 6 months
- •There is a history of sustained systemic corticosteroid treatment within 1 month
- •Needs simultaneous surgical treatment of other diseases；
- •Gastric cancer complications (bleeding, perforation, obstruction) require emergency surgery
- •Pulmonary function test FEV<1 predicted value 50%
结局指标
主要结局
Effects of quality of life
时间窗: The quality of life questionnaire was conducted at six months after surgery.
The GSRS scoring system was used to understand the functional status of the digestive tract and its impact on quality of life in postoperative patients .The GSRS scoring system was 0-3, with 0 being the mildest and 3 being the most severe
次要结局
未报告次要终点
研究者
Xue Yingwei
Director, Head of Gastrointestinal surgery, Principal Investigator, Clinical Professor
The Third Affiliated Hospital of Harbin Medical University