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IRCT20190325043107N29 IRCT 2022-04-28 Tabriz University of Medical Sciences Blind anal fistula treatment (BAFT) for anal fistula treatment Evaluation of blind anal fistula treatment (BAFT) for anal fistula treatment 2022-05-05 anticipated 50 Complete https://irct.ir/trial/62850 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block random division method (4 blocks) is used. One of the study partners, for whom blindness has not been performed, names the treatment with the letters A and B. The researcher then distributes packages A and B among the patients referred to participate in the study by block random division method (4). Then, from the created blocks, enough blocks are randomly selected to reach the required sample size. How to create a random sequence using randomization was simple. To make a random sequence, we give possible blocks (6 blocks) from one to 6 numbers. Depending on the sample size, any number of 4 blocks that are needed will be used. Select the number of blocks from the table of random numbers and based on these numbers, the sequence of blocks in each group will be determined, Blinding description: In this study, the data analyzer will be unaware of the grouping of patients and will only analyze the data; Therefore, the person analyzing the results will be blind during the study. 2-3 Pain. Intervention 1: Intervention group: A total of 25 patients will be included in this group after random allocation. Patients will be hospitalized and then transferred to the operating room. The BAFT method will then be used for their surgery. Before surgery and two weeks after surgery, the severity of pain and the extent of anal fistula healing in patients will be evaluated. Intervention 2: Control group: A total of 25 patients will be included in this group after random allocation. Patients will be hospitalized and then transferred to the operating room. Then the routine method of anal fistula surgery will be used for their surgery. Before surgery and two weeks after surgery, the severity of pain and the extent of anal fistula healing in patients will be evaluated. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences scientific Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Candidate for preanal fistula surgery 18 years 75 years Both History of diabetes Patients with coagulation problems Patients with inflammatory bowel disease G89.29 Other chronic pain Treatment - Surgery Treatment - Surgery Intervention group: A total of 25 patients will be included in this group after random allocation. Patients will be hospitalized and then transferred to the operating room. The BAFT method will then be used for their surgery. Before surgery and two weeks after surgery, the severity of pain and the extent of anal fistula healing in patients will be evaluated. Control group: A total of 25 patients will be included in this group after random allocation. Patients will be hospitalized and then transferred to the operating room. Then the routine method of anal fistula surgery will be used for their surgery. Before surgery and two weeks after surgery, the severity of pain and the extent of anal fistula healing in patients will be evaluated. Pain. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Visual analog scale. Anal fistula healing. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Physical examination. Tabriz University of Medical Sciences Approved 2022-02-16 Ethics committee of Tabriz University of Medical Sciences Imam Reza Hospital, Azadi Ave Tabriz East Azarbaijan Iran (Islamic Republic of)