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IRCT20080907001224N2 IRCT 2019-11-24 Mashhad University of Medical Sciences evaluation for effect of perforator deep vein ligation in side to side cubital arteriovenous fistula in kidney dialysis patients. Comparative evaluation for effect of perforator deep vein ligation in maturation and complications of side to side cubital arteriovenous fistula in kidney dialysis patients. 2019-01-21 anticipated 44 Complete https://irct.ir/trial/38930 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Table of randomized numbers using statistical software. The envelope method is such that the envelopes are prepared and printed by a member of the surgical team (outside the research team),Random numbers with the help of statistical software inserted inside the envelope. Pocket doors will be closed and its contents are not visible from the outside. First, the purpose of the study is explained to the person who follows the conditions and the person, if desired, signs the informed consent form and removes the envelope and then opens it and, based on the contents of the envelope, enters into the intervention or control group, Blinding description: The statistical analyst will be unaware of the intervention and control groups. Blinding is not feasible for the active researcher in the project due to surgery performance. Patients under study, active radiologist in the current design, allocator to the groups and statistical analyst are unaware of the patient group. N/A Chronic kidney disease, stage 5. Intervention 1: Intervention group: Patients in this group will undergo deep vein perforator ligation with silk suture 3.0. Intervention 2: Control group: Patients in this group will not undergo deep vein perforator ligation. Yes - There is a plan to make this available What will be shared: The whole potential data is published after being unidentifiable. When: The start of the access period will be 6 months after the publication of the results. To whom: Data will only be available to researchers working in academic and scientific institutions. Conditions: Any analysis on the delivered data is allowed. Where to obtain: Access to the study documentation will be possible by contacting the Surgery Research Center at Alavi Hospital.The contact number and address, email and site center are listed in the previous sections How to obtain: After submitting the request and approval to the Center's research committee, the documentation will be sent to the applicant within approximately 1 month. Comments:
public Hasan Ravari
Vascular and endovascular research center, Alavi hospital, Emam Reza 61
Mashhad Iran (Islamic Republic of) 9173856693 +98 51 3851 3258 ravarih@mums.ac.ir Mashhad University of Medical Sciences scientific Hasan Ravari
Vascular and endovascular research center, Alavi hospital, Emam Reza 61
Mashhad Iran (Islamic Republic of) 9173856693 +98 51 3851 3258 ravarih@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Informed consent Age>18 Having general conditions for the creation of arteriovenous fistula No history of hypotension 18 years no limit Both Dissatisfaction with the patient to continue the study The absence of appropriate anatomical criteria for an appropriate side to side anastomosis. (during surgery) End-side anastomosis based on anatomical criteria during surgery N18.5 Chronic kidney disease, stage 5 Treatment - Surgery Treatment - Surgery Intervention group: Patients in this group will undergo deep vein perforator ligation with silk suture 3.0. Control group: Patients in this group will not undergo deep vein perforator ligation. Cephalic vein maturation and Suitability for hemodialysis based on doppler ultrasonography. Timepoint: 1 week, 1 month, 3 months. Method of measurement: Maturation criteria based on the color doppler sonography is :flow >600 milliliter/Minute, cephalic length >10 Centimeters Or Two 4 Centimeters Segments; cephalic diameters>6 millimeters and < 5 millimeters Deep From Skin Surface. Venous hypertension. Timepoint: 1 week, 1 month, 3 months. Method of measurement: The excessive flow of intravenous retrograde leads to intravenous hypertension, which is accompanied by a change in the color of the blue, edema, dilatation of the veins and the color change of the organ in the physical examination. Steal syndrome. Timepoint: 1 week, 1 month, 3 months. Method of measurement: Steal syndrome refers to the diversion of arterial flow into another vascular bed, which does not meet the tissue needs of the target organ, and is manifested by symptoms such as pain, weakness, tissue loss and ulcers in the physical examination. General Surgical Complications. Timepoint: 1 week, 1 month, 3 months. Method of measurement: Complications such as infection, seroma and hematoma are detected in a physical examination. Mashhad University of Medical Sciences Approved 2019-02-26 Ethics committee of mashhad University of Medical Sciences Vascular and endovascular research center,Alavi Hospital,Mashhad,emam reza 61 Mashhad Razavi Khorasan Iran (Islamic Republic of)