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NCT Number: NCT06855914

Outcomes of Surgical Management of Aneurysmal Arteriovenous Fistula in Hemodialysis Patients

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

surgerical repair

Procedure

surgical repair of AVF aneurysm

Primary outcomes

  1. evaluate patency after surgical repair

    Time frame: baseline

    evaluate patency after surgical repair of aneurysmal arteriovenous fistula

  2. evaluate success rate after repair

    Time frame: baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

abanoub saad anis, master

CONTACT

[email protected]

+201288140668

mahmoud ismael ahmed, prof doctor

CONTACT

[email protected]

+201006228283

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2025
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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