Efficacy and Safety of Preoperative Enema in the Prevention of Catheter Dysfunction in Peritoneal Dialysis: A RCT Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 136
- 主要终点
- Incidence of Catheter dysfunction requiring intervention within 3 months of peritoneal dialysis catheterization
研究概览
简要总结
A prospective, randomized, controlled study was conducted to identify patients with end-stage renal disease who required open peritoneal dialysis catheterization, preoperative enema or no enema was used to evaluate the efficacy and safety of reducing catheter dysfunction.
详细描述
A prospective, randomized, controlled study was conducted to identify patients with end-stage renal disease who required open peritoneal dialysis catheterization, preoperative enema or no enema was used to evaluate the efficacy and safety of reducing catheter dysfunction. All the patients were divided into two groups: preoperative enema group and no intervention group. The peritoneal dialysis malfuction were observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Maintenance peritoneal dialysis treatment is required for end-stage Renal Disease;
- •First-time open surgeon peritoneal dialysis catheterization patient;
- •Only straight double-cuff Tenckhoff dialysis catheters were used.
- •Willing to participate in this study and sign informed consent form.
排除标准
- •peritoneal dialysis contraindication;
- •Enema contraindication;
- •Patients refuse enema;
- •Expected survival time < 3 months;
- •Catharsis such as Senna Leaf and lactulose used before operation or colonic dialysis and enema used 3 days before operation.
结局指标
主要结局
Incidence of Catheter dysfunction requiring intervention within 3 months of peritoneal dialysis catheterization
时间窗: 3 months
Time of first peritoneal dialysis catheter dysfunction
时间窗: 6 months
次要结局
- Incidence of peritoneal dialysis-associated Peritonitis(6 months)
- Incidence of Catheter dysfunction requiring intervention within 6 months of peritoneal dialysis catheterization(6 months)
- Catheter survival time(6 months)
研究者
Shiren sun
director of nephrology
Air Force Military Medical University, China