Uncut Roux-en-Y vs Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- the incidence of Roux stasis syndrome
研究概览
简要总结
Uncut Roux-en-Y vs Roux-en-Y reconstruction after distal gastrectomy for gastric cancer
详细描述
To search which is the better reconstructions by comparing and analyzing the advantages and disadvantages between Uncut Roux-en-Y and Roux-en-Y reconstructions after laparoscopy-assisted distal gastrectomy for gastric cancer.
Method: It's a prospective study including all patients underwent laparoscopy-assisted distal gastrectomy (LADG) in the First Hospital of Jilin University. All surgical procedures will be performed by the single surgery team, which is leaded by professor Wang Quan. The reconstruction method will be selected randomly from Uncut Roux-en-Y and Roux-en-Y anastomosis preoperatively without distinct indications. All clinical data, operation data, perioperative complications and related physiological indexes after surgery will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of distal gastric cancer
- •underwent laparoscopy-assisted distal gastrectomy
排除标准
- •have simultaneously other cancer
- •have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
- •have upper gastrointestinal surgery
- •can't bear the gastric tube
- •the period is too late or the tumor is too large to carry on a laparoscopy assisted radical distal gastrectomy
结局指标
主要结局
the incidence of Roux stasis syndrome
时间窗: 3 month after surgery
the incidence of Roux stasis syndrome after Roux-en-Y reach an incidence of over 30% which involve nausea, vomiting, and abdominal distension. So the incidence of both reconstructions should be compared.
次要结局
- the quility of life according to the RGB standards(12 month after surgery)
- the incidence of other complications after operation(one month after surgery)
研究者
Dong Yang
Assisted Investigator
Jilin University