Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis

October 18, 2023 updated by: Ahmed Abdallah Yahya Mohamed Fouda, Kafrelsheikh University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: anchor technique
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
End-to-side AV anastomosis was created in upper limb between cephalic vein and brachial or radial artery
Active Comparator: parachute technique
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
End-to-side AV anastomosis was created in upper limb between cephalic vein and brachial or radial artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

Investigators

  • Principal Investigator: ahmed fouda, MD, Kafrelsheikh University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2022

Primary Completion (Estimated)

January 5, 2024

Study Completion (Estimated)

January 5, 2024

Study Registration Dates

First Submitted

October 11, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKSU 50-12-8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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