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临床试验/NCT01704313
NCT01704313Unknown不适用

A Randonimised Trial Comparing Interrupted to Continuous Suturing Techniques in Radiocephalic Fistulae

Emma Aitken2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
70
试验地点
2
主要终点
Primary patency

研究概览

简要总结

Patients with end-stage renal failure require dialysis to remove toxins from their blood. Haemodialysis is best provided through a native arterio-venous fistula (AVF). Creation of an AVF requires a short (~1hr) surgical procedure to join the artery and vein together.

There are limited potential sites for fistula creation. Generally it is preferrable to utilise the most distal sites at the wrist first, as more proximal elbow procedures preclude subsequent use of the wrist should the initial fistula fail. The small diameter of artery and vein at the wrist requires precise surgical technique.

There are two potential techniques in common use for creating the arterio-venous anastomosis (the join between artery and vein) - continuous suturing and interrupted sutures. Whilst there are theoretical advantages to the interrupted technique, it is uncertain if these translate clinically into better success of creating the fistula. The aim of this study is therefore to compare the clinical success of the two techniques.

详细描述

The micro-vascular anastamosis required for creation of a radio-cephalic arteriovenous fistula, is technically challenging surgery. Primary patency rates for radiocephalic fistula varying between 50-75% in the literature and 60-95% within over own department. It is important to optimise primary patency rates as initial failure subjects the patient to risks of further surgery and often necessiates them commencing dialysis via a tunnelled line (which is less effective and associated with increased risks of infection) whilst a second attempt at creating a fistula is undertaken.

Multiple variations of both continuous and interrupted suture technique are described in the vascular literature, both in animal models of arterio-venous fistulae and in clinical studies in other specialities. However no study has compared the two techniques within clinical practice.

Evidence from in vivo animal studies is variable. Several authors have shown no difference in primary patency rates achieved with continuous suture versus interrupted suture technique used for anastomosis(Chen & Chen, 2001; Wilasrusmee et al 2007). Others have suggested that using a continuous suture causes a reduced cross-sectional area of the anastomosis compared to an interrupted technique (Tozzi & Hayoz, 2001). Similarly an interrupted suture technique permits expansion of the vessel at physiological pressures where as continuous technique does not (Norbert & Philip, 1996; Gerdisch & Hinkamp, 2003). This loss of compliance at the anastomosis can in turn lead to intimal hyperplasia, causing poor blood flow and failure of the anastamosis (Dorbin, 1994), indicating potential theoretical benefits of interrupted suturing.

There are no clinical studies comparing the two techniques and variation in practice varies considerably. The aim of this study therefore is the compare patency rates in radiocephalic fistulae by randomising to one or other anastomotic technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

  • End stage renal failure
  • Undergoing surgery for creation of a radiocephalic fistula

排除标准

  • Declines participation
  • Unable to speak English or provide informed consent
  • Radial artery diameter <1.8mm
  • Cephalic wrist diameter at wrist <2mm

结局指标

主要结局

Primary patency

时间窗: 6 weeks

Primary patency is defined by the unequivocal presence of a thrill/ bruit and unassisted maturation a to permit dialysis

次要结局

  • Secondary patency(6 weeks, 1 year)
  • Primary patency(1 year)

研究者

发起方
Emma Aitken
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Emma Aitken

Clinical Research Fellow, Renal Surgery

NHS Greater Glasgow and Clyde

研究点 (2)

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