Clinical trial NCT06855914: Outcomes of Surgical Management of Aneurysmal Arteriovenous Fistula in Hemodialysis Patients
Official title: Outcomes of Surgical Management of Aneurysmal Arteriovenous Fistula in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arteriovenous Fistula Patency
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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 .

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

Primary outcomes:
measure: evaluate patency after surgical repair
timeFrame: baseline
measure: evaluate success rate after repair
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.