Brachio Basilic Arterio Venous Fistula One Stage vs Two Stage

NCT06336226 | Not Yet Recruiting

• 1 other identifier: BB AVF one stage vs two stage
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this work was to compare primary failure rates and the primary functional patency of one-stage vs two stage brachiobasilic fistulas to compare the two surgical techniques .

Conditions

Arterio-venous Fistula

Outcome Measures

Primary Outcomes (1)

• Comparative study between one stage brachio basilic arterio venous fistula versus two stage

  Measures were primary fistula failure rates and patency rates at specific checkpoints.

  1 year

Study Arms (2)

One stage group

ACTIVE COMPARATOR

The one-stage operation was performed under regional anesthesia. A 5-cm incision at the ante cubital fossa identifies the basilic vein. The incision was extended proximally, and the underlying deep fascia was opened. The basilic vein was mobilized up to its junction with the brachial vein. The median cutaneous nerve of the forearm was carefully dissected and preserved. After side branches were ligated, the basilic vein was tunnelled subcutaneously, with a Roberts' forceps maintaining its axial orientation.An end-to-side arteriovenous anastomosisto the brachial artery was performed

Procedure: Brachio basilic arterio venous fistula one stage versus two stage

two stage group

ACTIVE COMPARATOR

he first stage of the two-stage procedure was performed under local anesthesia by formation of the arteriovenous anastomosis with minimal disturbance of the basilic vein. After 4 to 6 weeks, a flow assessment of the AVF by duplex scanning was made to determine if revision of the anastomosis was necessary at the second stage. The second stage was performed under regional anesthesia. The entire length of the basilic vein was mobilized, a"subcutaneous flap" was created, and the vein was positioned anterolaterally. Usually, a further 2 weeks was required before the AVF can be used

Procedure: Brachio basilic arterio venous fistula one stage versus two stage

Interventions

Brachio basilic arterio venous fistula one stage versus two stage PROCEDURE

Comparative study between one stage brachio basilic arterio venous fistula versus two stage

One stage group; two stage group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with end-stage renal disease who had their BBAVFs created either by the one-stage or two- stage technique.
• Patients with brachial artery diameter more than 3 . mm by duplex ultrasound (DUS).
• Patients with triphasic brachial artery by DUS.
• Patients with basilic vein diameter more than 3 mm by DUS.
• Patients who were able to give informed consent.
• Requirements for intervention agreement between the patient and the surgeon.
• Availability of patients for all follow-up visits.

You may not qualify if:

• Patients who already had a suitable cephalic vein for arteriovenous fistula creation.
• Patients whose brachial artery diameter was less than 3 mm by DUS.
• Patients with brachial artery disease proved by DUS.
• Patients whose basilic vein diameter was less than mm by DUS.
• Patients with ischemic cardiomyopathy.
• Patients with central venous stenosis or occlusion evidenced by duplex scanning.
• Patients with flexion deformity or skin lesions at the site of the fistula or over the course of the vein.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Bashar K, Healy DA, Elsheikh S, Browne LD, Walsh MT, Clarke-Moloney M, Burke PE, Kavanagh EG, Walsh SR. One-stage vs. two-stage brachio-basilic arteriovenous fistula for dialysis access: a systematic review and a meta-analysis. PLoS One. 2015 Mar 9;10(3):e0120154. doi: 10.1371/journal.pone.0120154. eCollection 2015.

  PMID: 25751655 BACKGROUND

• Kakkos SK, Lampropoulos GC, Nikolakopoulos KM, Tsolakis IA, Papadoulas SI, Papachristou EC, Goumenos D, Lazarides MK. A Systematic Review and Meta-Analysis of Randomized Trials Comparing Two-Stage with One-Stage Brachio-Basilic Vein Fistulas. Vasc Specialist Int. 2018 Sep;34(3):51-60. doi: 10.5758/vsi.2018.34.3.51. Epub 2018 Sep 30.

  PMID: 30310807 BACKGROUND

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 Officials

• Haitham A Hasan, Professor

  Assiut University

  STUDY CHAIR

• Ahmed Kh Sayed, Lecturer

  Assiut University

  STUDY DIRECTOR

• Wael A Abdelgawad, Lecturer

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed AM Abdelrasheed, Resident

CONTACT

01032735951; ahmeddawood2597@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: May 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share