A Single Center Randomized Prospective Study on the Peristaltic Direction of Gastrointestinal Anastomosis in Roux-en-Y Reconstruction After Distal Curative Gastrectomy for Gastric Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Early postoperative recovery results
研究概览
简要总结
The aim of this study is intending to provide the optimal procedures of the peristaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer, which can provide the best operation mode of Roux-en-Y anastomosis in digestive tract reconstruction during distal gastrectomy for reducing postoperative complications and improving quality of life for patients.
详细描述
In this study, all 148 the included patients will underwent the distal curative gastrectomy for gastric cancer and will be performed the Roux-en-Y reconstruction for gastrointestinal anastomosis. Of them, 74 patients will be randomized in the group undergoing with the isoperistaltic anastomosis in the Roux-en-Y reconstruction procedure. Meanwhile, the other 74 cases will be randomized in the group undergoing with the antiperistaltic anastomosis in the Roux-en-Y reconstruction procedure. Then, we will evaluate the differencies of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.) and late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.) between above two group of patients, which will make an important contribution to reduce medical costs and potential improvements of the prognosis after distal curative gastrectomy for gastric cancer.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological examination confirmation the adenocarcinoma of stomach before surgery
- •Physical conditions compliance with the requirements for curative gastrectomy
- •Consent to undergo the D2 lymphadenectomy, and the dissected proportion of stomach no less than 2/3
- •Comply with the protocol during the whole study period
- •No neoadjuvant therapy administration
- •Sign informed consent and permission of withdraw in the whole study period
- •Consent to provide the tissue specimens after surgery for this study
- •Estimation the overall survival after surgery no less than 6 months
- •No anesthesia or operation contraindication disease
- •cT1-4N0-2M0 stage demonstration by CT and endoscopic ultrasonography examinations
- •Negative cytological detection in operation
- •No seriously concomitance's diseases
- •Karnofsky Performance Scores (KPS) more than 60
- •Examined lymph node count no less than 16
排除标准
- •Women during pregnant stage and breast-feed stage
- •Women of childbearing age without any contraceptive measures
- •Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
- •Immunosuppressive therapists for organ transplantation
- •Seriously uncontrolled recurrent infection
- •other malignant tumors
- •No abilities of self-knowledge or mental disorders
- •Participating in other clinical trials
- •Siewert I and II esophagogastric junction tumors
- •Serious internal diseases obstruction surgery
结局指标
主要结局
Early postoperative recovery results
时间窗: Within 1 month after surgery
Differences of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.)
Late postoperative recovery results
时间窗: 1 year after surgery
Differences of late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.)
次要结局
未报告次要终点