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PRIMARY EFFICACY OUTCOME MEASURE (MATURATION) WAS SIGNIFICANT, IN FAVOR OF THE TW0-STAGE PROCEDURE
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Arteriovenous fistulas (AVFs) are made by joining a vein to an artery in order to get the vein dilated with sufficient blood flow in order to puncture the vein and clear the blood from wastes, in patients whose kidneys are destroyed and cannot provide this function. The success rate of this procedure varies between 50-80% and depends mainly on the size of the vein, with success being higher with larger veins. One of the veins used for an AVF is the basilic vein, located at the upper arm. This vein is however deeply located and necessitates movement (transposition) during surgery to a less deep and lateral path before it is joined to the artery, in order to be used. A single study has shown that surgery performed in two parts (one to enlarge the vein and the second one to relocate the enlarged vein under the wound, not in a new path) is more successful than doing the procedure altogether.
The aim of this study is to confirm the findings of the single study mentioned above (one versus two stages of basilic vein AVF), with the difference that the vein will be relocated outside the main wound, a method that is widely accepted as being better.
Arteriovenous fistulas (AVFs) are made by anastomosing a vein to an artery in order to get the vein dilated with sufficient blood flow in order to puncture the vein and perform hemodialysis in patients with renal failure. The success rate of this procedure varies between 50-80% and depends mainly on the size of the vein, with success being higher with larger veins. One of the veins used for an AVF is the basilic vein, located at the upper arm. This vein is however deeply located and necessitates transposition during surgery to a less deep and lateral subcutaneous plane before the anastomosis with the artery, in order to be used. A single study has shown that surgery performed in two stages (one to enlarge the vein and the second one to relocate the enlarged vein under the wound, not in a new path) is more successful than doing the procedure in one stage.
The aim of this study is to confirm the findings of the single study mentioned above (one versus two stages of basilic vein AVF), with the difference that the basilic vein will be relocated outside the main wound, a method that is widely accepted as being better.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One-stage transposition of the basilic vein | Placebo Comparator | One-stage transposition of the basilic vein |
|
| Two-stage transposition of the basilic vein | Experimental | Two-stage transposition of the basilic vein |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transposition of the basilic vein and anastomosis with the brachial vein | Procedure | One-stage vs two-stage transposition of the basilic vein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maturation rate | Usage of the AVF (or clearance in case of pre-hemodialysis) | 6-10 weeks |
| Long term primary, primary assisted and secondary patency | Long term primary, primary assisted and secondary patency | 1-3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | Hematoma, steal syndrome, venous hypertension | 1-3 years |
| Basilic vein size | Basilic vein size on ultrasound | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stavros Kakkos, MD, PhD | University of Patras | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Patras | Pátrai | Achaia | 265034 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9754891 | Background | El Mallah S. Staged basilic vein transposition for dialysis angioaccess. Int Angiol. 1998 Jun;17(2):65-8. | |
| 25973421 | Result | Kakkos SK, Tsolakis IA, Papadoulas SI, Lampropoulos GC, Papachristou EE, Christeas NC, Goumenos D, Lazarides MK. Randomized controlled trial comparing primary and staged basilic vein transposition. Front Surg. 2015 Apr 29;2:14. doi: 10.3389/fsurg.2015.00014. eCollection 2015. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000714 | Anastomosis, Surgical |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| 35493925 | Derived | Wang J, Gong X, Chen H, Zhong W, Chen Y, Zhou Y, Zhang W, He Y, Lou M. Causative Classification of Ischemic Stroke by the Machine Learning Algorithm Random Forests. Front Aging Neurosci. 2022 Apr 15;14:788637. doi: 10.3389/fnagi.2022.788637. eCollection 2022. |
| 31920571 | Derived | Kaneko F, Shindo K, Yoneta M, Okawada M, Akaboshi K, Liu M. A Case Series Clinical Trial of a Novel Approach Using Augmented Reality That Inspires Self-body Cognition in Patients With Stroke: Effects on Motor Function and Resting-State Brain Functional Connectivity. Front Syst Neurosci. 2019 Dec 17;13:76. doi: 10.3389/fnsys.2019.00076. eCollection 2019. |
| 30687164 | Derived | Battaglia G, Alesi M, Tabacchi G, Palma A, Bellafiore M. The Development of Motor and Pre-literacy Skills by a Physical Education Program in Preschool Children: A Non-randomized Pilot Trial. Front Psychol. 2019 Jan 9;9:2694. doi: 10.3389/fpsyg.2018.02694. eCollection 2018. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |