Arterio-venous FistulaNCT06091839
Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis
A study testing suturing technique in arteriovenous fistula creation for hemodialysis in people with Arterio-venous Fistula, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterio-venous Fistula
- What is being tested?
- suturing technique in arteriovenous fistula creation for hemodialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2022to 5 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Introduction
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).
- Conditions
- Arterio-venous Fistula
- Being tested
- suturing technique in arteriovenous fistula creation for hemodialysis
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suturing technique in arteriovenous fistula creation for hemodialysisOther
End-to-side AV anastomosis was created in upper limb between cephalic vein and brachial or radial artery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: suturing technique in arteriovenous fistula creation for hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Complication rate and failure of maturation
Bleeding, infection, steal syndrome, and aneurysmal dilatation at the anastomosis site.
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start2 Mar 2022
- Primary completion5 Jan 2024
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Arterio-venous FistulaStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdullah Yahya Mohamed Fouda, Kafrelsheikh University
- Investigators
- ahmed fouda, MD, Principal investigator, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091839
- Sponsor's protocol ID
- MKSU 50-12-8
- Status last verified
- Apr 2025
- First submitted
- 11 Oct 2023
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17986697Ibbotson 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.
PubMed 1397782Pozzoni 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.
PubMed 15599892Lee 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.
PubMed 19911442Baboolal 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.
PubMed 18174268Johansen 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.
PubMed 35331382Lok 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.
PubMed 32778223Celik 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.
PubMed 32962489Bray 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.
PubMed 22908320Lin 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.
PubMed 15806274Achneck 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.
PubMed 20331815Konner 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.
PubMed 23125423
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anchor Versus Parachute Suturing Technique in Arteriovenous Fistula Creation for Hemodialysis
- ClinicalTrials.gov ID
- NCT06091839
- Acronym / sponsor ID
- MKSU 50-12-8
- Conditions
- Arterio-venous Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anchor technique | Active comparator | Other: suturing technique in arteriovenous fistula creation for hemodialysisIn 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. |
| parachute technique | Active comparator | Other: suturing technique in arteriovenous fistula creation for hemodialysisIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| suturing technique in arteriovenous fistula creation for hemodialysisEnd-to-side AV anastomosis was created in upper limb between cephalic vein and brachial or radial artery | Other | anchor technique, parachute technique |
Primary outcome
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.
1 secondary outcome
Complication rate and failure of maturation
Time frame: Six Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Background: PubMed 17986697Coresh 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.
- Background: PubMed 1397782Ibbotson 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.
- Background: PubMed 15599892Pozzoni 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.
- Background: PubMed 19911442Lee 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.
- Background: PubMed 18174268Baboolal 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.
- Background: PubMed 35331382Johansen 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.
- Background: PubMed 32778223Lok 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.
- Background: PubMed 32962489Celik 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.
- Background: PubMed 22908320Bray 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.
- Background: PubMed 15806274Lin 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.
- Background: PubMed 20331815Achneck 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.
- Background: PubMed 23125423Konner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed fouda, MD principal investigator
Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suturing technique in arteriovenous fistula creation for hemodialysis in people with Arterio-venous Fistula, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Maturation of Arterio-venous Fistula (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06091839, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.