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IRCT20200217046525N1 IRCT 2020-02-21 Esfahan University of Medical Sciences Comparison of the efficacy and side effects of intravenous-arterial fistula methods in hemodialysis فیستول وریدی-شریانی Comparison of efficacy and complications of end-side anastomosis of brachial artery to cubital perforating vein versus side-side brachiocephalic arteriovenous fistula formation in hemodialysis candidates at alzahra hospital 2016-08-31 anticipated 85 Complete https://irct.ir/trial/45838 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were recruited individually and were randomly with using spermatozoa, assigned to two groups(Group One-Group Two).The first group underwent cephalic vein avf fistula and brachial artery laterally and the second group underwent cephalic vein avf fistula and brachial artery, Blinding description: Patients were not informed of their surgical procedure until the end of the study. Patients were followed up at the clinic by a specialist surgeon in three stages (postoperative day, one week postoperative and 12 weeks postoperative). The doctor did not know the type of surgery and the purpose of the study. 3 Kidney failure. Intervention 1: Intervention group: Intravenous-arterial fistula by anastomosis lateral to perforated branch of cephalic vein to brachial artery and brachiocephalic fistula. Intervention 2: Intervention group: Creation of intravenous-arterial fistula by anastomosis side-by-side perforan branch of cephalic vein to brachial artery and brachiocephalic fistula. Yes - There is a plan to make this available What will be shared: At the time of publishing the data, no personal data of any participants will be published and only information on the outcome of the study will be reported. When: Documentation will be available 6 months after the end of the study. To whom: Study data will be available only to researchers working in academic institutions Conditions: In order to receive data or other study documentation, a written request and the reason for the data need to be sent to the project manager. Where to obtain: In order to receive study data refer to the study lead: Dr. Sarokhani: Address:Department of Surgery, Alzahra Hospital, Sofeh Boulevard, Isfahan phone number:-03138227000-09121813678 Fax: 03136684510 Email: saroukhaniabbas@yahoo.com How to obtain: To access the study data and documentation, the reason for the need for data and the type of data required should be sent to the Department of Surgery of Isfahan University of Medical Sciences through an official letter from the Institute of Research and Research. Comments:
public Saroukhani Abbas
Department of Surgery, Alzahra Hospital, Sofeh Boulevard, Isfahan
Esfahan Iran (Islamic Republic of) 8174675731 +98 31 3822 7000 saroukhaniabbas@yahoo.com Esfahan University of Medical Sciences scientific Saroukhani Abbas
Department of Surgery, Alzahra Hospital, Safeh Boulevard, Isfahan
Esfahan Iran (Islamic Republic of) 8174675731 098 31 38227000 saroukhaniabbas@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patient with hemodialysis Patient with fistula implantation in elbow (including inappropriate vein or artery in wrist, previous failure of fistula in wrist) Patient's consent to participate in the study No intravenous injection into the elbow area at least two weeks before surgery Systolic blood pressure above 110 mm Hg before surgery 40 years 80 years Both Fistula embolization due to underlying vascular problems (calcification and venous thrombosis) Inability to perform fistula without displacement due to venous topography N18, N18.5 Chronic kidney disease, stage 5 Treatment - Surgery Treatment - Surgery Intervention group: Intravenous-arterial fistula by anastomosis lateral to perforated branch of cephalic vein to brachial artery and brachiocephalic fistula Intervention group: Creation of intravenous-arterial fistula by anastomosis side-by-side perforan branch of cephalic vein to brachial artery and brachiocephalic fistula Early efficacy of intravenous arterial fistula. Timepoint: Every two weeks until preparation for dialysis. Method of measurement: Physical examination by using checklists. Late efficacy of intravenous arterial fistula. Timepoint: Day after surgery, one week after surgery and 12 weeks after surgery. Method of measurement: Measurement of blood flow at the fistula site. Steel Syndrome and Functional Deficiency. Timepoint: Day after surgery, one week after surgery and 12 weeks after surgery. Method of measurement: Physical examination. Esfahan University of Medical Sciences Approved 2016-05-24 Ethics committee of Esfahan University of Medical Sciences Department of Surgery, Alzahra Hospital, Safeh Boulevard, Isfahan Esfahan Isfehan Iran (Islamic Republic of)