Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis

Not Applicable

Completed

• Conditions: Arterio-venous Fistula

• 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

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