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IRCT20130812014333N148 IRCT 2020-04-23 Kermanshah University of Medical Sciences Study the effect of enema with iodine on infection rate after transrectal prostate biopsy in patients suspected of prostate cancer Effect of enema with iodine on infection rate after transrectal prostate biopsy in patients suspected of prostate cancer in Imam Reza Hospital during years 2016-2019 2020-04-28 anticipated 230 Complete https://irct.ir/trial/47181 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the random number table, patients are divided into three groups of 115. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the first intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the second intervention group, Blinding description: In this study, data analysts is kept blind to the allocation of study groups. 2-3 acute prostatitis. Intervention 1: The intervention group will receive 600 cc betadine with 100 cc lidocaine by injected into the rectum and after 5 minutes the prostate biopsy will be performed with the normal saline enema. Intervention 2: The control group will not receive any intervention. Yes - There is a plan to make this available What will be shared: The main outcomes of the study will be shared When: 3 months To whom: If requested, results will be made available to other academic researchers Conditions: Collected data is confidential and will not be shared with anyone else Where to obtain: Send E-mail to the responsible for the update to get the documentation How to obtain: Documentation will be emailed within a 15-day timeframe Comments:
public Ramin Ardeshiri
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 Ramin.ardeshiri100@gmail.com Kermanshah University of Medical Sciences scientific Dr. Farajolah Parhoudeh
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 fparhoudeh@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Patients whose serum PSA levels have increased Age between 50-68years 50 years 68 years Male Patients with normal rectal tenderness N41.0 Acute prostatitis Treatment - Drugs Other The intervention group will receive 600 cc betadine with 100 cc lidocaine by injected into the rectum and after 5 minutes the prostate biopsy will be performed with the normal saline enema. The control group will not receive any intervention. Pain severity. Timepoint: The beginning of the study and one day after the end of the intervention. Method of measurement: Using visual scale of pain (VAS). Body temperature. Timepoint: The beginning of the study and one day after the end of the intervention. Method of measurement: Using a thermometer. Kermanshah University of Medical Sciences Approved 2019-11-04 Ethics committee of Kermanshah University of Medical Sciences Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences Kermanshah Kermanshah Iran (Islamic Republic of)