Comparison of proximal arteriovenous fistula anastomosis side by side to end in patients with chronic renal failure

Comparison of side-to-side and side-to-end proximal arteriovenous fistula anastomosis in patients with chronic kidney failure.

Randomized, parallel-group, single-blind, phase 3 clinical trial on 72 patients. In this study, block method with Sealed Envelope software will be used for randomization.

It is a single-blind clinical trial study that will be conducted in Valiasr Hospital in Arak city in 2022. In this study, patients who are candidates for arteriovenous fistula surgery who have the inclusion and exclusion criteria are included in the study. It is recorded in a checklist, this information includes age, sex, study group, bleeding, underlying disease, thrombosis, infection, pain, fistula maturation. These examinations are performed after surgery and It continues every two weeks until the fistula matures. Blinding is done in such a way that the performed technique is not known to the patient and each patient does not know about his anastomosis method.

Inclusion criteria: all patients who are candidates for arteriovenous fistula. exclusion criteria: liver disease, pregnancy

In this study, the participants are divided into two groups A (end-to-side anastomosis) and group B (side-to-side anastomosis). In group A, the anastomosis was performed with the technique of connecting the end of the artery to the side of the vein in the proximal, and in group B, the anastomosis was performed with the technique of connecting the side of the artery to the side of the vein in the proximal.

Bleeding, ،Thrombosis, Pain at the fistula site, Fistula maturation

The participants will be assigned to two groups A and B based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate the samples. In this way, by using the block method random number generation software, the randomization sequence will be produced according to the required sample size for two groups. In the beginning, all the modes that can arrange 2 letters A and B in a block of 8 are produced. Then a block will be selected randomly and by placement among the blocks, and the arrangement pattern in that block will be used to allocate the participants. Then this block will be placed in the main container and another block will be selected again. All these works will be done with a software called Sealed Envelope. In this method, concealment will also be observed. The concept of concealment is the unpredictability of assigning people to groups. In fact, the researcher will not be able to predict which group the next person will be in.

Because this operation is performed while the patient is under anesthesia, the technique performed is not known to the patient, and each patient does not know his anastomosis method. But the project managers and outcome evaluators are aware of the type of anastomoses performed for patients and study groups.