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IRCT20200825048515N47 IRCT 2021-10-29 Esfahan University of Medical Sciences The effectiveness of using Surgicel in reducing bleeding in patients undergoing prostatectomy Evaluation of the effectiveness of using Surgicel in reducing bleeding in patients undergoing suprapubic simple open prostatectomy 2021-11-21 anticipated 54 Complete https://irct.ir/trial/59582 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 54 eligible patients will be randomly selected. For this, the letter A is written on 27 sheets, and the letter B is written on 27 sheets and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups, Blinding description: Due to the nature of the present study, the surgeon will be aware of the type of surgery in each of the two groups, but the patient and the evaluator (data collector) will not be aware of the type of surgery in each group. 3 Suprapubic simple open prostatectomy. Intervention 1: Intervention group: In this surgical group, suprapubic simple open prostatectomy will be performed according to standard techniques, but after removing the prostate adenoma inside the prostate cavity, Surgicel will be used. In this way, for a prostate weighing 75 grams, two pieces and with the increase in the weight of the prostate, for every 25 grams of weight gain, an additional number of Surgicel will be placed inside the prostate cavity and other steps will be performed until the end of surgery with standard techniques. Intervention 2: Control group: all surgical procedures will be performed according to the standard technique of suprapubic simple open prostatectomy, and Surgicel will not be used. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Reza Kazemi
Ostandari street.
Isfahan Iran (Islamic Republic of) 8145831451 +98 31 3222 2127 dr.rezakazemi6788@gmail.com Esfahan University of Medical Sciences scientific Reza Kazemi
Ostandari street.
Isfahan Iran (Islamic Republic of) 8145831451 +98 31 3222 2127 dr.rezakazemi6788@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Candidate patients for suprapubic simple open prostatectomy Satisfaction to participate in the study no limit no limit Male History of any prostate surgery Consumption of anti-platelets and anticoagulants History of hereditary bleeding diseases N52.34 Erectile dysfunction following simple prostatectomy Treatment - Surgery N/A Intervention group: In this surgical group, suprapubic simple open prostatectomy will be performed according to standard techniques, but after removing the prostate adenoma inside the prostate cavity, Surgicel will be used. In this way, for a prostate weighing 75 grams, two pieces and with the increase in the weight of the prostate, for every 25 grams of weight gain, an additional number of Surgicel will be placed inside the prostate cavity and other steps will be performed until the end of surgery with standard techniques. Control group: all surgical procedures will be performed according to the standard technique of suprapubic simple open prostatectomy, and Surgicel will not be used. Hemoglobin. Timepoint: Before surgery, immediately, 24 and 48 hours after surgery. Method of measurement: Blood test. Hematocrit. Timepoint: Before surgery, immediately, 24 and 48 hours after surgery. Method of measurement: Blood test. Bleeding volume. Timepoint: During and after surgery. Method of measurement: The amount of blood sucked. Isfahan University of Medical Sciences Approved 2021-07-16 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)