Clinical trial NCT06091839: Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis
Official title: Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterio-venous Fistula
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled study to compare the results of two surgical techniques for AVF creation, including the anchor technique (Group A) and parachute technique (Group B).

The study population will be patients referred to the Vascular surgery department for the creation of Hemodialysis access. Patients will be advised to undergo elective surgery for AVF once their renal Glomerular Filtration Rate Estimated (eGFR) is less than 15 ml/min.

primary outcome: Functional Maturation of Arterio-venous Fistula \[ Time Frame: Six Months\] Ready fistula for cannulation, vein length at least 10 cm, diameter more than 6 mm, depth not more than 6 mm, and ability of the access to deliver a flow rate of 600ml/min and maintain dialysis for 4 hours.

Detailed description: Introduction

Aim of the work To compare the results of two surgical techniques for AVF creation, including the anchor technique (Group A) and parachute technique (Group B).

Patients and the method Study location: We will submit the study protocol for approval by Kafr ElSheikh medical research ethics committee, faculty of medicine, Kafr ElSheikh University.

Study design: Randomized controlled study will be conducted in the department of vascular surgery in Kafr El Sheikh.

Time of study: We started in march 2022.

Study population: The study population will be patients referred to the Vascular surgery department for the creation of Hemodialysis access. Patients will be advised to undergo elective surgery for AVF once their renal Glomerular Filtration Rate Estimated (eGFR) is less than 15 ml/min.

The number of patients:

This study will be done on 150 cases, 75 cases in group A (anchor technique) and another 75 in group B (parachute technique).

Eligibility criteria: Inclusion Criteria:

* Eighteen years of age or older.
* Need for AVF creation for vascular access for planned hemodialysis (within one year), Including distal - Radio-cephalic, proximal brachio-cephalic configurations.
* Vein mapping studies completed 2.5-3 mm minimum vein diameter on mapping.

Exclusion Criteria:

* Ipsilateral proximal venous and arterial occlusion or stenosis
* systemic or local infection at the site planned for AVF creation.
* Anticipated inability to keep 30-day post-operative follow-up appointment.
* Revision AVF, Synthetic graft AVF, or lower limb AVF.
* Patients with absent distal pulses and chronic ischemia of the upper limb.
* Recent cannulation of puncture of the vein within two weeks before its use in AVF creation.
* Vasculitis (collagen diseases)

Primary outcomes:
measure: Functional Maturation of Arterio-venous Fistula
timeFrame: 6 months
Secondary outcomes:
measure: Complication rate and failure of maturation
timeFrame: Six Months
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
Study officials:
affiliation: Kafrelsheikh University
name: ahmed fouda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA. 2007 Nov 7;298(17):2038-47. doi: 10.1001/jama.298.17.2038.
citation: Ibbotson SH, Walmsley D, Davies JA, Grant PJ. Generation of thrombin activity in relation to factor VIII:C concentrations and vascular complications in type 1 (insulin-dependent) diabetes mellitus. Diabetologia. 1992 Sep;35(9):863-7. doi: 10.1007/BF00399933.
citation: Pozzoni P, Del Vecchio L, Pontoriero G, Di Filippo S, Locatelli F. Long-term outcome in hemodialysis: morbidity and mortality. J Nephrol. 2004 Nov-Dec;17 Suppl 8:S87-95.
citation: Lee CP, Chertow GM, Zenios SA. An empiric estimate of the value of life: updating the renal dialysis cost-effectiveness standard. Value Health. 2009 Jan-Feb;12(1):80-7. doi: 10.1111/j.1524-4733.2008.00401.x.
citation: Baboolal K, McEwan P, Sondhi S, Spiewanowski P, Wechowski J, Wilson K. The cost of renal dialysis in a UK setting--a multicentre study. Nephrol Dial Transplant. 2008 Jun;23(6):1982-9. doi: 10.1093/ndt/gfm870. Epub 2008 Jan 3.
citation: Johansen KL, Chertow GM, Gilbertson DT, Herzog CA, Ishani A, Israni AK, Ku E, Li S, Li S, Liu J, Obrador GT, O'Hare AM, Peng Y, Powe NR, Roetker NS, St Peter WL, Saeed F, Snyder J, Solid C, Weinhandl ED, Winkelmayer WC, Wetmore JB. US Renal Data System 2021 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2022 Apr;79(4 Suppl 1):A8-A12. doi: 10.1053/j.ajkd.2022.02.001. No abstract available.
citation: Lok CE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, Allon M, Asif A, Astor BC, Glickman MH, Graham J, Moist LM, Rajan DK, Roberts C, Vachharajani TJ, Valentini RP; National Kidney Foundation. KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update. Am J Kidney Dis. 2020 Apr;75(4 Suppl 2):S1-S164. doi: 10.1053/j.ajkd.2019.12.001. Epub 2020 Mar 12.
citation: Celik S, Gok Oguz E, Ulusal Okyay G, Selen T, Ayli MD. The impact of arteriovenous fistulas and tunneled cuffed venous catheters on morbidity and mortality in hemodialysis patients: A single center experience. Int J Artif Organs. 2021 Apr;44(4):229-236. doi: 10.1177/0391398820952808. Epub 2020 Sep 22.
citation: Bray BD, Boyd J, Daly C, Donaldson K, Doyle A, Fox JG, Innes A, Khan I, Peel RK, Severn A, Shilliday I, Simpson K, Stewart GA, Traynor J, Metcalfe W; Scottish Renal Registry. Vascular access type and risk of mortality in a national prospective cohort of haemodialysis patients. QJM. 2012 Nov;105(11):1097-103. doi: 10.1093/qjmed/hcs143. Epub 2012 Aug 20.
citation: Lin PH, Bush RL, Nguyen L, Guerrero MA, Chen C, Lumsden AB. Anastomotic strategies to improve hemodialysis access patency--a review. Vasc Endovascular Surg. 2005 Mar-Apr;39(2):135-42. doi: 10.1177/153857440503900202.
citation: Achneck HE, Sileshi B, Li M, Partington EJ, Peterson DA, Lawson JH. Surgical aspects and biological considerations of arteriovenous fistula placement. Semin Dial. 2010 Jan-Feb;23(1):25-33. doi: 10.1111/j.1525-139X.2009.00651.x.
citation: Konner K, Lomonte C, Basile C. Placing a primary arteriovenous fistula that works--more or less known aspects, new ideas. Nephrol Dial Transplant. 2013 Apr;28(4):781-4. doi: 10.1093/ndt/gfs463. Epub 2012 Nov 2.