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IRCT20221211056784N1 IRCT 2022-12-26 Mazandaran university of medical science Fistulectomy with or with out primery repair Evaluation clinical consequence of fistulectomy with or with out immediate sphincteroplasty in the treatment of anal fistula 2022-12-12 anticipated 72 Complete https://irct.ir/trial/67362 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: By calculating the sample size, taking into account a certain number of patients, they will be divided into two equal groups, the number of measurement times is 4 times. The sample collection is based on the goal and based on the entry and exit criteria. In order to randomly allocate the samples to two groups, a simple random method will be used, which is determined by the qualified patient's referral based on the entry and exit criteria, and by using a table of random numbers and selecting even or odd numbers for the allocation of the patient to the relevant group. The study is blinded from the point of view of the patients and the evaluator, and the patient and the evaluator are not aware of the possible outcomes and complications after the operation, but the surgeon knows, Blinding description: In order to randomly allocate the samples to two groups, a simple random method will be used, which is determined by the qualified patient's referral based on the entry and exit criteria, and by using a table of random numbers and selecting even or odd numbers for the allocation of the patient to the relevant group. The study is blinded from the point of view of the patients and the evaluator, and the patient and the evaluator are not aware of the possible outcomes and complications after the operation, but the surgeon is. N/A Anal fistula. Intervention 1: Intervention group: primary sphincteroplasty after fistulectomy in this group after fistulectomy is performed simultaneously in the same primary tissue repair operation with thread. And the results of this type of tissue repair, including the rate of recurrence and incontinence, are compared with the control group. Intervention 2: Control group: fistulectomy without sphincteroplasty. In this group, after sphincterotomy, the tissue defect is repaired in a secondary way and over time, and there is no intervention after sphincterotomy for repair. 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 After the end of the study, a decision is made to publish individual data
public Akram kalani
Imam khomeini hospital., Amir mazandarani Ave .,Sari., Iran
Ghaemshahr Iran (Islamic Republic of) ۴۷۳۴۳۴۷۶۴۶ +98 11 4204 1154 neda_kalani22@yahoo.com Mazandaran University of Medical Sciences scientific Akram kalani
Imam khomeini hospital., Amir mazandarani Ave .,Sari., Iran
Sari Iran (Islamic Republic of) ۴۷۳۴۳۴۷۶۴۶ +98 11 4204 1154 neda_kalani22@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patient with anal fistula in 15_80 age 15 years 80 years Both Pregnancy History of anal surgery Coagulation disorder K60.3 Anal fistula Treatment - Surgery Treatment - Surgery Intervention group: primary sphincteroplasty after fistulectomy in this group after fistulectomy is performed simultaneously in the same primary tissue repair operation with thread. And the results of this type of tissue repair, including the rate of recurrence and incontinence, are compared with the control group Control group: fistulectomy without sphincteroplasty. In this group, after sphincterotomy, the tissue defect is repaired in a secondary way and over time, and there is no intervention after sphincterotomy for repair. Recurrence rate. Timepoint: One week, two weeks, 1, 3, 6 and 12 months after the surgery, the patients are re-examined and they are studied in recurrence rate. Method of measurement: through a questionnaire. Gas and stool incontinence. Timepoint: One week, two weeks, 1, 3, 6 and 12 months after the surgery. Method of measurement: through a questionnaire. Postoperative satisfaction rate. Timepoint: One week, two weeks, 1, 3, 6 and 12 months after the surgery. Method of measurement: through a questionnaire. Mazandaran university of medical science Approved 2022-03-16 Ethics Committee of Sari University of Medical Sciences Imam khomeini hospital., Amir mazandarani Ave .,Sari., Iran Sari Mazandaran Iran (Islamic Republic of)