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NCT Number: NCT06091839

Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis

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.

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Key information

Conditions

Arterio-venous Fistula Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafr ash Shaykh, 6860404, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

suturing technique in arteriovenous fistula creation for hemodialysis

Other

End-to-side AV anastomosis was created in upper limb between cephalic vein and brachial or radial artery

Primary outcomes

  1. Functional Maturation of Arterio-venous Fistula

    Time frame: 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 outcomes

  1. Complication rate and failure of maturation

    Time frame: Six Months

    Bleeding, infection, steal syndrome, and aneurysmal dilatation at the anastomosis site.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2023
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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