A Prospective Randomized Controlled Trial of Local Anaesthetic Percutaneous Insertion Versus General Anaesthetic Open Surgical Placement of Continuous Peritoneal Dialysis Catheters in a University Teaching Hospital
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Catheter survival
研究概览
简要总结
Healthy kidneys clean your blood by removing excess fluid, minerals, and wastes. When your kidneys fail, harmful wastes build up in your body and your body may retain excess fluid. When this happens, you need treatment to replace the work of your failed kidneys. This may be with a dialysis machine using haemodialysis or with fluid in the abdomen or peritoneal dialysis.
In peritoneal dialysis, a tube called a catheter is put in the abdomen wall and used to fill your abdomen with a cleansing liquid called dialysis solution. The walls of your abdominal cavity are lined with a membrane called the peritoneum, which allows waste products and extra fluid to pass from your blood into the dialysis solution. These wastes and fluid are removed from the body when the dialysis fluid is drained and replaced with a fresh solution.
The tubes or catheters used to exchange the fluid are currently positioned using a general anaesthetic (with the patient awake) and an operation with a cut under the belly button. Newer techniques using local anaesthetic (with the patient awake and the area numbed) and requiring only a small cut in the skin have been used. No one has ever directly compared the two techniques.
The investigators aim is to perform a direct comparison between the two techniques to look at the complications and time required for surgery and length of hospital stay required. The investigators will also look at the patients satisfaction and pain scores with each technique to help gather evidence as to which is likely to be the best technique to use from now on.
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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Open insertion
To undergo insertion of catheter using open technique under general anaesthetic
干预措施: Open insertion Catheter (Procedure)
Percutaneous insertion
To undergo insertion of catheter using percutaneous technique under local anaesthetic
干预措施: Percutaneous Insertion catheter (Procedure)
结局指标
主要结局
Catheter survival
时间窗: Ongoing (recorded at 6 month intervals)
Time to catheter removal for any reason.recorded as percentage inn situ at 6, 12,18,etc months post procedure.
次要结局
- Patient reported pain post procedure(24 hour intervals to 5 days post procedure)
- Peri operative complications (bleeding, bowel injury)(24 hrs post procedure)
- Operative time(Average of 2 hours post procedure)
- Length of admission(Average of 48 hours post procedure)
- Infective complications (exit site, tunnel, peritonitis)(ongoing (reported at 30 days and monthly thereafter))
- Quality of life assessment by questionnaire(Within 24 hours prior to procedure, and again at both 5 days and 3 months post procedure)
- Mechanical Complication (drainage failure, displacement, fluid leak)(ongoing (reported at 30 days and monthly thereafter))
- Technical Success of placement(Average of 2 hours post procedure)
- Estimated cost of care episode(3 months post procedure)
