Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction in Patients With Gastric Cancer. A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- incidence of small bowel obstruction
研究概览
简要总结
To assess whether the use of Seprafilm reduces the rate of small bowel obstruction in patients who underwent surgery for gastric cancer.
详细描述
Patients with gastric cancer who were scheduled to undergo gastrectomy were randomly assigned to a sodium hyaluronate-based bioresorbable membrane (Seprafilm) group or to a control group. Before closing the abdominal incision, two sheets of Seprafilm membrane were applied to the surface of the small intestine under the middle abdominal wound in the Seprafilm group. The primary end point was the incidence of bowel obstruction. Secondary end points were intraoperative and postoperative morbidity and mortality.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 79 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of gastric cancer
排除标准
- •Withdrew consent
- •Distant metastasis
- •Liver dysfunction (serum total bilirubin >2.0 mg/dL)
- •Renal failure (serum creatinine >1.5 mg/dL)
- •A past history of small bowel obstruction.
结局指标
主要结局
incidence of small bowel obstruction
时间窗: 3 years, more than 6 months after gastrectomy
次要结局
- intraoperative and postoperative morbidity and mortality.(3 years)
