The Safety and Effectiveness of Clipped Technique vs. Hand-Sewn Technique for Anastomosis in Arteriovenous Fistulas
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Patency rates
研究概览
简要总结
The purpose of this study is to determine whether handsewn anastomosis versus clipped technique is associated with more complications, fistula failures, surgical cost and surgical time.
详细描述
End stage renal disease requiring hemodialysis has become more prevalent in recent years. Achieving vascular access is an important step in receiving hemodialysis. Recent national goals have established that approximately 65% of all dialysis access points should be arteriovenous fistulas due to higher patency rates and decreased rates of further surgeries. Multiple studies have been done to assess optimal suture technique for arteriovenous anastomoses. The use of clips versus a handsewn technique has been evaluated in retrospective studies with some reports indicating a higher primary patency rate with a clip technique. Further study is needed to definitively determine the technique that results in the highest patency rates and lowest rate of re-operation. The purpose of this study is to determine whether hand-sewn anastomosis versus a clipped technique is associated with more complications, failures, surgical cost and surgical time by randomizing patients to either a clipped anastomosis group or a handsewn anastomosis group.
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
- Single (Participant)
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
- •18 years of age or older.
- •Need for AVF creation for vascular access for planned hemodialysis (within 1 year).
- •The planned AVF site must be naïve of prior AVF creations.
- •Vein mapping studies completed
- •2.5 - 3mm minimum vein diameter on mapping
排除标准
- •Less than 18 years of age.
- •Inability to provide consent.
- •Previous failed AVFs in both arms.
- •Contraindications to AVF creation:
- •ipsilateral proximal venous and arterial occlusion or stenosis
- •systemic or local infection
- •too ill to operate
- •Anticipated inability to keep 30-day postoperative follow-up appointment.
结局指标
主要结局
Patency rates
时间窗: 2 years postoperative
Patency will be assessed and the fistula considered patent if it has been accessed for dialysis at least once, or based on clinical assessment with palpable thrill if dialysis access has not been attempted.
次要结局
- Surgical complications(2 years postoperative)
研究者
Kara Kallies
Advanced Research Associate, on behalf of Clark Davis, MD (PI)
Gundersen Lutheran Medical Foundation
