Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis

Study Overview
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Brief Summary
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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
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Introduction End-stage kidney disease (ESKD) is increasing worldwide and is likely to increase further because of aging populations and the increased prevalence of type II diabetes mellitus. It is a chronic and irreversible condition associated with substantial morbidity and high mortality and constitutes a heavy financial burden on healthcare systems. The reduced hemodialysis-related mortality rate has increased the need for dependable vascular access. For end-stage renal failure patients, arteriovenous fistulas (AVFs) are the reliable hemodialysis access option. Compared to tunneled central venous catheters, they had a reduced risk of systemic sepsis and a lower overall cardiovascular death rate. Numerous factors for early failure and arrested maturation have been implicated, including abnormal anastomotic hemodynamics, the diameter of the vein, hyperplasia of intima and stenosis or scarring, insufficient arterial flow, and suture technique. The surgical technique is an essential aspect in determining AVF surgery success. The lack of data supporting any anastomotic suture technique is better in AV access patency, or less complication makes the choice of suture technique for AV access formation dependent on the operator's discretion and their best clinical judgment. For this reason, we conducted prospective research on AVFs created using two distinct continuous suturing techniques, the anchor technique, and the parachute technique, to examine the impact of these two techniques on the initial outcomes of AVFs. 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).

Official Title
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Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis

Conditions
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Arterio-venous Fistula

Intervention / Treatment
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* Other: suturing technique in arteriovenous fistula creation for hemodialysis


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: anchor technique<br>In the anchor technique , the suture was secured first at the heel region after entering the artery and the vein in an inside-out fashion, and a surgical knot was tied, after which the suture was run continuously across the lateral margins of anastomosis, entering the vein outside-in and the artery inside-out, from heel (proximal end of arteriotomy) to toe (distal end). Then the suture was run to complete suturing the medial margins from heel to toe, entering the artery outside-in and the vein inside-out, and final knots were taken. | Other: suturing technique in arteriovenous fistula creation for hemodialysis<br>* End-to-side AV anastomosis was created in upper limb between cephalic vein and brachial or radial artery<br>|
| Active Comparator: parachute technique<br>In the parachute technique, suture was first secured at 11 o'clock position entering both vessels in an inside-out fashion, then continuous suturing was commenced towards 5 o'clock position across the heel, entering the vein outside-in and the artery inside-out, without approximating the vessels. Then, gentle traction was applied on the sutures to allow even distribution of tension along the suture-line and 'parachuting' or approximation of vessel walls together. The suture was then run in a continuous fashion across the proximal margin (toward surgeon) and across the toe region, and finally, surgical knots were applied at midway on the distal margin. | Other: suturing technique in arteriovenous fistula creation for hemodialysis<br>* End-to-side AV anastomosis was created in upper limb between cephalic vein and brachial or radial artery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Maturation of Arterio-venous Fistula | The suitability of an AVF for successful cannulation for dialysis, ascertained by duplex ultrasound study by measuring vein length at least 10 cm, diameter more than 6 mm, depth for skin not more than 6 mm, and ability of the access to deliver a flow rate of 600ml/min and maintain dialysis for 4 hours. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate and failure of maturation | Bleeding, infection, steal syndrome, and aneurysmal dilatation at the anastomosis site. | Six Months |