search
Back to results

Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis

Primary Purpose

Arterio-venous Fistula

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
suturing technique in arteriovenous fistula creation for hemodialysis
Sponsored by
Kafrelsheikh University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterio-venous Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Kafrelsheikh UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

anchor technique

parachute technique

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Complication rate and failure of maturation
Bleeding, infection, steal syndrome, and aneurysmal dilatation at the anastomosis site.

Full Information

First Posted
October 11, 2023
Last Updated
October 18, 2023
Sponsor
Kafrelsheikh University
search

1. Study Identification

Unique Protocol Identification Number
NCT06091839
Brief Title
Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis
Official Title
Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2022 (Actual)
Primary Completion Date
January 5, 2024 (Anticipated)
Study Completion Date
January 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterio-venous Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anchor technique
Arm Type
Active Comparator
Arm Description
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.
Arm Title
parachute technique
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
suturing technique in arteriovenous fistula creation for hemodialysis
Intervention Description
End-to-side AV anastomosis was created in upper limb between cephalic vein and brachial or radial artery
Primary Outcome Measure Information:
Title
Functional Maturation of Arterio-venous Fistula
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Complication rate and failure of maturation
Description
Bleeding, infection, steal syndrome, and aneurysmal dilatation at the anastomosis site.
Time Frame
Six Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fouda, MD
Phone
201092424389
Email
ahmed.med_0124@med.kfs.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed fouda, MD
Phone
201092424389
Email
ahmed.med_0124@med.kfs.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmed fouda, MD
Organizational Affiliation
Kafrelsheikh University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kafrelsheikh University
City
Kafr Ash Shaykh
ZIP/Postal Code
6860404
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Fouda, MD
Phone
201092424389
Email
ahmed.med_0124@med.kfs.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17986697
Citation
Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA. 2007 Nov 7;298(17):2038-47. doi: 10.1001/jama.298.17.2038.
Results Reference
background
PubMed Identifier
1397782
Citation
Ibbotson SH, Walmsley D, Davies JA, Grant PJ. Generation of thrombin activity in relation to factor VIII:C concentrations and vascular complications in type 1 (insulin-dependent) diabetes mellitus. Diabetologia. 1992 Sep;35(9):863-7. doi: 10.1007/BF00399933.
Results Reference
background
PubMed Identifier
15599892
Citation
Pozzoni P, Del Vecchio L, Pontoriero G, Di Filippo S, Locatelli F. Long-term outcome in hemodialysis: morbidity and mortality. J Nephrol. 2004 Nov-Dec;17 Suppl 8:S87-95.
Results Reference
background
PubMed Identifier
19911442
Citation
Lee CP, Chertow GM, Zenios SA. An empiric estimate of the value of life: updating the renal dialysis cost-effectiveness standard. Value Health. 2009 Jan-Feb;12(1):80-7. doi: 10.1111/j.1524-4733.2008.00401.x.
Results Reference
background
PubMed Identifier
18174268
Citation
Baboolal K, McEwan P, Sondhi S, Spiewanowski P, Wechowski J, Wilson K. The cost of renal dialysis in a UK setting--a multicentre study. Nephrol Dial Transplant. 2008 Jun;23(6):1982-9. doi: 10.1093/ndt/gfm870. Epub 2008 Jan 3.
Results Reference
background
PubMed Identifier
35331382
Citation
Johansen KL, Chertow GM, Gilbertson DT, Herzog CA, Ishani A, Israni AK, Ku E, Li S, Li S, Liu J, Obrador GT, O'Hare AM, Peng Y, Powe NR, Roetker NS, St Peter WL, Saeed F, Snyder J, Solid C, Weinhandl ED, Winkelmayer WC, Wetmore JB. US Renal Data System 2021 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2022 Apr;79(4 Suppl 1):A8-A12. doi: 10.1053/j.ajkd.2022.02.001. No abstract available.
Results Reference
background
PubMed Identifier
32778223
Citation
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. Erratum In: Am J Kidney Dis. 2021 Apr;77(4):551.
Results Reference
background
PubMed Identifier
32962489
Citation
Celik S, Gok Oguz E, Ulusal Okyay G, Selen T, Ayli MD. The impact of arteriovenous fistulas and tunneled cuffed venous catheters on morbidity and mortality in hemodialysis patients: A single center experience. Int J Artif Organs. 2021 Apr;44(4):229-236. doi: 10.1177/0391398820952808. Epub 2020 Sep 22.
Results Reference
background
PubMed Identifier
22908320
Citation
Bray BD, Boyd J, Daly C, Donaldson K, Doyle A, Fox JG, Innes A, Khan I, Peel RK, Severn A, Shilliday I, Simpson K, Stewart GA, Traynor J, Metcalfe W; Scottish Renal Registry. Vascular access type and risk of mortality in a national prospective cohort of haemodialysis patients. QJM. 2012 Nov;105(11):1097-103. doi: 10.1093/qjmed/hcs143. Epub 2012 Aug 20.
Results Reference
background
PubMed Identifier
15806274
Citation
Lin PH, Bush RL, Nguyen L, Guerrero MA, Chen C, Lumsden AB. Anastomotic strategies to improve hemodialysis access patency--a review. Vasc Endovascular Surg. 2005 Mar-Apr;39(2):135-42. doi: 10.1177/153857440503900202.
Results Reference
background
PubMed Identifier
20331815
Citation
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.
Results Reference
background
PubMed Identifier
23125423
Citation
Konner K, Lomonte C, Basile C. Placing a primary arteriovenous fistula that works--more or less known aspects, new ideas. Nephrol Dial Transplant. 2013 Apr;28(4):781-4. doi: 10.1093/ndt/gfs463. Epub 2012 Nov 2.
Results Reference
background

Learn more about this trial

Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis

We'll reach out to this number within 24 hrs