End-to-side Versus Side-to-side Anastomosis With Distal Vein Ligation for Arteriovenous Fistula Creation

NCT04222881 | Completed

• 1 other identifier: R.18.02.24 - 2018/02/04
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

End-stage renal disease (ESRD) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years.End-stage renal disease (ESRD) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years. Haemodialysis (HD) is a lifeline therapy for patients with ESRD. Our study to compare methods of AVF creation, side to side and end to side . This randomized controlled trial .

Conditions

Arterio-venous Fistula

Keywords

End to side anastomosis of arteriovenous fistula

Outcome Measures

Primary Outcomes (1)

• Functional Maturation of Arterio-venous Fistula

  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 350 to 400ml/min and maintain dialysis for 4 hours.

  Six Months

Secondary Outcomes (1)

• Complication rate and failure of maturation

  Six Months

Study Arms (2)

End To Side

End to Side Anastomosis

Procedure: AVF anastomosis

Side To Side

Side To Side Anastomosis

Procedure: AVF anastomosis

Interventions

AVF anastomosis PROCEDURE

Type of arteriovenous anastomosis

End To Side; Side To Side

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

• Study population will be on Patients referred to Vascular surgery department for creation of Hemodialysis access. Patients will advised to undergo elective surgery for AVF once their renal Glomerular Filtration Rate Estimated (eGFR) is less than 15 ml/min.

You may qualify if:

• All renal failure patients requiring creation of arm AVF
• Including distal Radio-cephalic, Ulno-basilic, proximal brachio-cephalic or brachio-basilic configurations

You may not qualify if:

• 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 2 weeks before its use in AVF creation.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura

Al Mansurah, Mansoura University, 35111, Egypt

Location

MeSH Terms

Conditions

Arteriovenous Fistula

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: February 4, 2018
• Primary Completion: September 4, 2018
• Study Completion: February 4, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

EG (1)