Prospective Open Randomized Study to Evaluate the Efficiency of Prophylactic Fenestration of the Peritoneum in Kidney Transplantation in Preventing the Occurrence of Postoperative Lymphoceles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Incidence of symptomatic lymphoceles
研究概览
简要总结
A single centre open randomised parallel-group study to evaluate whether prophylactic fenestration of the peritoneum at the time of renal transplantation prevents lymphocele formation.
Adult (>18 years old) recipients of renal transplants from deceased donors were eligible for inclusion. From March 2007 to May 2009 130 patients were included. The patients were randomized either to peroperative peritoneal fenestration, or to serve as controls. Block-randomization was conducted in groups of 10, drawn from envelopes containing five notes from each group. Patients who previously had undergone extensive abdominal surgery, or were included in other studies were excluded.
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
- •Adult recipients of kidney transplants from deceased donors
排除标准
- •Former extensive abdominal surgery
- •Participation in other studies
结局指标
主要结局
Incidence of symptomatic lymphoceles
时间窗: 1 - 3 years
Symptomatic lymphoceles treated by surgical intervetion or ultrasound guided drainage
次要结局
- Prevalence of fluid perirenal collections evaluated by ultrasound at 1, 5 and 10 weeks(1 -10 weeks)