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IRCT20231031059918N1 IRCT 2023-11-13 Yazd University of Medical Sciences Comparing the effectiveness of Ciprofloxacin, Ceftriaxone, and Gentamicin for preventing bacteriuria after transurethral lithotripsy (TUL) Comparing the effectiveness of Ciprofloxacin, Ceftriaxone, and Gentamicin for preventing bacteriuria after transurethral lithotripsy (TUL) 2023-11-25 anticipated 264 Complete https://irct.ir/trial/73638 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Allocating the samples to the intervention groups will be through the creation of a random sequence using the permutation block method using the Random Allocation software and a computer-generated list of random numbers. Therefore it is done by a person not involved in the study and randomized codes are kept in sealed envelopes and open at the time of patient recruitment , Blinding description: Participants will not know which of the 3 antibiotics they will receive. However, Principal investigator, health care personnel and data collection officer will be informed. N/A Comparing the effectiveness of ciprofloxacin, ceftriaxone, and gentamicin for preventing bacteriuria after transurethral lithotripsy. Intervention 1: Intervention group: 88 patients use 1 g ceftriaxone 30 minutes before surgery. Intervention 2: Intervention group: 88 patients are injected with 400mg ciprofloxacin 30 minutes before surgery. Intervention 3: Intervention group: 88 patients are injected 2 mg/kg gentamicin 30 minutes before surgery. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts after the results are printed To whom: all of the people Conditions: There is no special condition Where to obtain: My postal address for correspondence, or email address, phone numbers How to obtain: There is no specific process Comments:
public nazanin Akhavan
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yazd Iran (Islamic Republic of) 8917956195 +98 35 3523 6600 nazanin1379akhavan@gmail.com Yazd University of Medical Sciences scientific Nazanin Akhavan
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Yazd Iran (Islamic Republic of) 8917956195 +98 35 3523 6600 nazanin1379akhavan@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Patients with middle and distal ureteral calculi with negetive urine culture that are going to undergo TUL (the maximum diameter of the stone is <2 cm) Age 18 to 65 years old. 18 years 65 years Both Asymptomatic patients with colony count ≥ 10 5 CFU/mL or a symptomatic UTI with colony count ≥ 10 3 CFU/mL Patients with any catheter. Patients with preoperative fever (body temperature ≥ 38°C) Patients with a history of diabetes. Patients with immunocompromised diseases or using immunosuppressive drugs Patients with abnormal renal function Patients who have received antimicrobial treatment within two weeks before enrollment Pregnant or breastfeeding women Patients who are allergic to our research drugs. Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: 88 patients use 1 g ceftriaxone 30 minutes before surgery Intervention group: 88 patients are injected with 400mg ciprofloxacin 30 minutes before surgery. Intervention group: 88 patients are injected 2 mg/kg gentamicin 30 minutes before surgery. Significant bacteriuria was defined asymptomatic patients with colony count ≥ 10 5 CFU/mL or a symptomatic UTI with colony count ≥ 10 3 CFU/mL. Timepoint: After 48 hour of surgery, routine urine tests and urine bacterial cultures, will be recorded. Method of measurement: Routine urine tests and urine bacteria culture are done in the Rahnemoun hospital laboratory. Febrile urinary tract infection (fUTI) is defined as a body temperature of 38.5 C accompanying urinary tract infection after surgery. Timepoint: After 48 hour of surgery. Method of measurement: body temperature by thermometer will be recorded. • SIRS criteria defined by: WBC < 4000 or > 12000 , heart rate > 90 per minute , temperature < 36 C or > 38 C , respiratory rate >20 or pCO2 < 32 . (Presence of two or more of these criteria is accepted as SIRS.). Timepoint: After 48 hour of surgery. Method of measurement: Routine urine tests and urine bacteria culture are done in the Rahnemoun hospital laboratory. Yazd University of Medical Sciences Approved 2023-11-08 Faculty of Medicine - Shahid Sadougi University of Medical Sciences, Yazd (Research Ethics Committee Jomhouri Boulevard, Alley 56, Seventh Alley, Second Dead End, Second House yazd Yazd Iran (Islamic Republic of)