跳至主要内容
临床试验/NCT01669850
NCT01669850终止不适用

The Safety and Effectiveness of Clipped Technique vs. Hand-Sewn Technique for Anastomosis in Arteriovenous Fistulas

Gundersen Lutheran Medical Foundation2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2012年8月1日最近更新:
适应症

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

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

发起方
Gundersen Lutheran Medical Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kara Kallies

Advanced Research Associate, on behalf of Clark Davis, MD (PI)

Gundersen Lutheran Medical Foundation

研究点 (2)

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