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Not yet recruiting NCT06855914

Outcomes of Surgical Management of Aneurysmal Arteriovenous Fistula in Hemodialysis Patients

No phase Interventional Arteriovenous Fistula Patency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: surgerical repair.
Who it may be relevant to
Registry conditions: Arteriovenous Fistula Patency. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

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 .

Interventions

  • Procedure surgerical repair
    surgical repair of AVF aneurysm

Primary outcome measures

  • evaluate patency after surgical repair [Time frame: baseline]
  • evaluate success rate after repair [Time frame: baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Stolic R. Most important chronic complications of arteriovenous fistulas for hemodialysis. Med Princ Pract. 2013;22(3):220-8. doi: 10.1159/000343669. Epub 2012 Nov 2. PMID 23128647
  • Santoro D, Benedetto F, Mondello P, Pipito N, Barilla D, Spinelli F, Ricciardi CA, Cernaro V, Buemi M. Vascular access for hemodialysis: current perspectives. Int J Nephrol Renovasc Dis. 2014 Jul 8;7:281-94. doi: 10.2147/IJNRD.S46643. eCollection 2014. PMID 25045278
  • 2. Abdel-Fattah El-Ballat M, Ahmed El-Sayed M, Kamel Abdel-Raouf Emam H. Epidemiology of End Stage Renal Disease Patients on Regular Hemodialysis in El-Beheira Governorate, Egypt. Vol. 76, The Egyptian Journal of Hospital Medicine. 2019.
  • Plonski A, Plonski AF, Glowinski J. Surgical Management, Prevention and Outcomes for Aneurysms of Arteriovenous Dialysis Fistulas: A Case Series Study and Review. Int J Environ Res Public Health. 2023 Jun 29;20(13):6256. doi: 10.3390/ijerph20136256. PMID 37444103

Identifiers

NCT: NCT06855914 · surgery in aneurysmal AVF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗