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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate and failure of maturation | Bleeding, infection, steal syndrome, and aneurysmal dilatation at the anastomosis site. | Six Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ahmed fouda, MD | Kafrelsheikh University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kafrelsheikh University | Kafr ash Shaykh | 6860404 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17986697 | Background | 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. | |
| 1397782 | Background | 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. |
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| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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Not provided
| ID | Term |
|---|---|
| D013536 | Suture Techniques |
| D006435 | Renal Dialysis |
| ID | Term |
|---|---|
| D058106 | Wound Closure Techniques |
| D013514 | Surgical Procedures, Operative |
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
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| 15599892 | Background | 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. |
| 19911442 | Background | 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. |
| 18174268 | Background | 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. |
| 35331382 | Background | 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. |
| 32778223 | 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. |
| 32962489 | Background | 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. |
| 22908320 | Background | 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. |
| 15806274 | Background | 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. |
| 20331815 | 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. |
| 23125423 | Background | 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. |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016060 | Sorption Detoxification |