Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis

Not Applicable

Completed

• Conditions: Arterio-venous Fistula
• Interventions: Other: suturing technique in arteriovenous fistula creation for hemodialysis

• Registration Number: NCT06091839
• Lead Sponsor: Kafrelsheikh University

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).

Study Timeline

• Study Start: 2022-03-02
• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-19
• Primary Completion: 2024-01-05
• Study Completion: 2024-01-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anchor technique	suturing technique in arteriovenous fistula creation for hemodialysis	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.
parachute technique	suturing technique in arteriovenous fistula creation for hemodialysis	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.

Primary Outcome Measures

Name	Time	Method
Functional Maturation of Arterio-venous Fistula	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Complication rate and failure of maturation	Six Months	Bleeding, infection, steal syndrome, and aneurysmal dilatation at the anastomosis site.

Trial Locations

Locations (1)

Kafrelsheikh University; 🇪🇬 Kafr Ash Shaykh, Egypt