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临床试验/NCT06855914
NCT06855914尚未招募不适用

Outcomes of Surgical Management of Aneurysmal Arteriovenous Fistula in Hemodialysis Patients

Assiut University0 个研究点目标入组 46 人开始时间: 2025年2月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
46
主要终点
evaluate patency after surgical repair

研究概览

简要总结

To evaluate the success rate and patency after surgical management of Arteriovenous fistulas aneurysms

详细描述

End-stage renal failure is a disease that can affect all organs. The increasing prevalence of affluent-society diseases such as obesity, diabetes, hypertension, or atherosclerosis means that the number of patients diagnosed with end-stage renal disease is systematically growing . Worldwide, the number of patients receiving hemodialysis is estimated at more than 1.4 million, with the annual incident rate growing to 8%, prevalence of ESRD in Egypt raised to 483 patients per million. A well-functioning vascular access is a mainstay to perform an efficient haemodialysis . AVF, described by Brescia and Cimino, remains the first choice for chronic Haemodialysis . It is the best access for longevity and has the lowest association with morbidity and mortality, and for this reason AVF use is strongly recommended by guidelines from different countries . The most common complications of fistulae for HD are lymphedema, infection, aneurysm, stenosis, congestive heart failure, steal syndrome, ischemic neuropathy and thrombosis. It is important to gain information about early clinical symptoms of AVF dysfunction in order to prevent and adequately treat potential complications . Arteriovenous fistula aneurysms are defined by an expansion of the intimal, medial and adventitial layers of the vessel wall to a diameter of more than 18 mm. Aneurysmal degeneration of the venous component of surgically created arteriovenous fistulae (AVFs) is a common clinical finding. prevalence rates ranging widely between 6% and 51% depending on criteria. Although arteriovenous fistula aneurysms (AVFAs) can be prone to thrombosis and can cause cosmetic dissatisfaction, the most catastrophic complication is life-threatening haemorrhage . The decision for surgical intervention relies on the risk of perforation, ulceration, bleeding, and size of aneurysm which leaves a limited space for puncture. The surgical modalities include excision of the aneurysm and primary repair, excision of the aneurysm and interposition graft , repair by end-to-end anastomosis, ligation .

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • •All patients with pseudo-aneurysms over AVF
  • •skin Changes ( Ulceration - Inflammation -Necrosis)
  • •Huge Enlargement with lack of potential site of Cannulation
  • •Impending thrombosis of the fistula
  • •Risk of infection and impending rupture
  • •Significant Cosmetic concerns causing distress to the patient

排除标准

  • •Bad general condition, patient with severe comorbidities
  • •Thrombosed AV fistula
  • •Age < 18 years
  • •Anastomotic aneurysms
  • •Venous Hypertension over AVF

研究组 & 干预措施

surgical repair

Experimental

surgical repair of AVF

干预措施: surgerical repair (Procedure)

结局指标

主要结局

evaluate patency after surgical repair

时间窗: baseline

evaluate patency after surgical repair of aneurysmal arteriovenous fistula

evaluate success rate after repair

时间窗: baseline

success rate of surgical repair of aneurysm and can use fistula for further dialysis or not

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

abanoub saad anis

Principal investigator

Assiut University

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