Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis

NCT06091839 | Completed DMC

• 1 other identifier: MKSU 50-12-8
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterio-venous Fistula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complication rate and failure of maturation

  Six Months

Study Arms (2)

anchor technique

ACTIVE COMPARATOR

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

parachute technique

ACTIVE COMPARATOR

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

Interventions

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

anchor technique; parachute technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, 6860404, Egypt

Location

Related Publications (12)

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  PMID: 15599892 BACKGROUND

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  PMID: 18174268 BACKGROUND

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  PMID: 35331382 BACKGROUND

• Lok CE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, Allon M, Asif A, Astor BC, Glickman MH, Graham J, Moist LM, Rajan DK, Roberts C, Vachharajani TJ, Valentini RP; National Kidney Foundation. KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update. Am J Kidney Dis. 2020 Apr;75(4 Suppl 2):S1-S164. doi: 10.1053/j.ajkd.2019.12.001. Epub 2020 Mar 12.

  PMID: 32778223 BACKGROUND

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  PMID: 32962489 BACKGROUND

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  PMID: 22908320 BACKGROUND

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  PMID: 15806274 BACKGROUND

• Achneck HE, Sileshi B, Li M, Partington EJ, Peterson DA, Lawson JH. Surgical aspects and biological considerations of arteriovenous fistula placement. Semin Dial. 2010 Jan-Feb;23(1):25-33. doi: 10.1111/j.1525-139X.2009.00651.x.

  PMID: 20331815 BACKGROUND

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  PMID: 23125423 BACKGROUND

MeSH Terms

Conditions

Arteriovenous Fistula

Interventions

Suture Techniques; Renal Dialysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Wound Closure Techniques; Surgical Procedures, Operative; Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Study Officials

• ahmed fouda, MD

  Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular surgery specialist

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 19, 2023
• Study Start: March 2, 2022
• Primary Completion: January 5, 2024
• Study Completion: January 5, 2024
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

EG (1)