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IRCT20180223038837N3 IRCT 2019-11-10 Kermanshah University of Medical Sciences Comparative study on the efficacy of flexion and non-flexin graft in dialysis patients during a six-month follow-up period Comparative study on the efficacy of flexion and non-flexin graft in dialysis patients during a six-month follow-up period 2019-11-20 anticipated 50 Complete https://irct.ir/trial/32044 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, a list of four random permutation blocks consisting of permutations of the letters B and A, for example AB and BA, was prepared by the statistical consultant using PAFF software. One person outside the selection researchers (operating room personnel) and qualified people are divided into groups. N/A Patients in need of dialysis. Intervention 1: Intervention group: In this group, the selected patients are transferred to the operating room. The procedure is determined on the arm and after washing the operation site, local anesthesia is injected into the ante cobital area and the axillary region and then the skin is cut. The subcutaneous is dissected and brachial and axillary vessels are exposed. Flexin graft is then anastomosis between brachial artery and axillary vein. Intervention 2: Control group: In this group, the selected patients are transferred to the operating room. The procedure is determined on the arm and after washing the operation site, local anesthesia is injected into the ante cobital area and the axillary region and then the skin is cut. The subcutaneous is dissected and brachial and axillary vessels are exposed. The jotec graft is then anastomotic between the brachial artery and the axillary vein. Yes - There is a plan to make this available What will be shared: in the case of the participant's data file, three months after the publication of the article , and after unidentification of the person, the request can be send by email When: Three months after the article is published, it is possible to send it by email. To whom: Researchers working in academic and scientific institutions Conditions: Mention the author's name in the extracted article. In this case, any statistical analysis is permitted. Where to obtain: By email with Dr. Mohammad Reza Sobhyeh Mreza.sobhiyeh@yahoo.com How to obtain: Up to one week after receiving the email, the requested documentation will be sent Comments:
public Mohammad Reza Sobhiyeh
Parstar Blvd
Kermanshah Iran (Islamic Republic of) 671441533 +98 912 183 7405 Mreza.sobhiyeh@yahoo.com Kermanshah University of Medical Sciences scientific Mohammad Reza Sobhiyeh
Parastar Blvd
Kermanshah Iran (Islamic Republic of) 671441533 +98 83 3427 6333 Mreza.sobhiyeh@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Written and informed patient satisfaction No previous history of central venous destruction No previous history of graft for dialysis no limit no limit Both Failure to cooperate for follow-up Immune-attenuating drug use Autoimmune disease Taking anti-coagulants Taking antibiotics Treatment - Devices Treatment - Devices Intervention group: In this group, the selected patients are transferred to the operating room. The procedure is determined on the arm and after washing the operation site, local anesthesia is injected into the ante cobital area and the axillary region and then the skin is cut. The subcutaneous is dissected and brachial and axillary vessels are exposed. Flexin graft is then anastomosis between brachial artery and axillary vein. Control group: In this group, the selected patients are transferred to the operating room. The procedure is determined on the arm and after washing the operation site, local anesthesia is injected into the ante cobital area and the axillary region and then the skin is cut. The subcutaneous is dissected and brachial and axillary vessels are exposed. The jotec graft is then anastomotic between the brachial artery and the axillary vein. Stenosis after graft insertion. Timepoint: One month after graft placement, three months after graft placement, six months after graft placement. Method of measurement: Color Doppler Ultrasound. Pseudoaneurism. Timepoint: One month after graft placement, three months after graft placement, six months after graft placement. Method of measurement: Examination and ultrasound. Central vein destruction. Timepoint: One month after graft placement, three months after graft placement, six months after graft placement. Method of measurement: Color Doppler Ultrasound. Infection rate. Timepoint: One month after graft placement, three months after graft placement, six months after graft placement. Method of measurement: examination. Kermanshah University of Medical Sciences Approved 2019-08-16 Ethics committee of Kermanshah University of Medical Sciences Imam reza hospital, parstar Blvd Kermanshah Kermanshah Iran (Islamic Republic of)