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IRCT20180625040232N11 IRCT 2023-10-27 Oroumia University of Medical Sciences Investigating the effect of normal saline irrigation temperature in patients undergoing percutaneous nephrolithotomy Investigating the effect of normal saline irrigation temperature on surgical outcomes of patients undergoing percutaneous nephrolithotomy 2023-11-22 anticipated 50 Complete https://irct.ir/trial/73300 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Participants will be randomly assigned to one of the hot or cold wash solution groups using computer-generated numbers produced by the Random allocation software. Thus, in this software, the number of groups and the total sample size will be entered, and then the "randomization" will be implemented in the block section. Then, the computer-generated number list will be given to the physician, and the physician will assign patients to groups according to the determined order by the software for entry into one of the groups.Thus, the randomization process will continue until the final sample size is reached, Blinding description: The study will be conducted as a double-blind clinical trial. The patient and the researcher who will be evaluating the outcomes will be blind to the allocation of patients into two groups. Washing process will be performed during percutaneous nephrolithotomy (PCNL) by a urologist (other than the outcome assessor) and finally the name of groups will be encoded with the letters A and B. 3 Kidney stone. Intervention 1: Intervention group: Patients in one group will be washed with cold washing solution (20-24°C) during PCNL. Intervention 2: Intervention group: Patients in the other group will be washed with warm solution (25-29°C) during PCNL. No - There is not a plan to make this available Justification or reason for not sharing IPD is En Confidentiality of patient information
public Dr. Saman Farshid
Imam Khomeini hospital, Ershad Ave, Modarres Blvd, Urmia, Iran.
Urmia Iran (Islamic Republic of) 57157-89397 +98 44 3345 7286 farshid.s@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Saman Farshid
Imam Khomeini hospital, Ershad Ave, Modarres Blvd, Urmia, Iran.
Urmia Iran (Islamic Republic of) 57157-89397 +98 44 3345 7286 farshid.s@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients with kidney stones with a diameter of more than 2-3 cm Patients with stones resistant to extracorporeal shock wave lithotripsy Patients with proximal ureter stones with a diameter of more than 1.5 cm Diverticular stones Age between 18 and 60 years 18 years 60 years Both Coagulation disorders Severe heart failure GB90 Certain specified disorders of kidney or ureter Other Other Intervention group: Patients in one group will be washed with cold washing solution (20-24°C) during PCNL. Intervention group: Patients in the other group will be washed with warm solution (25-29°C) during PCNL. Stone free rate. Timepoint: Second day after surgery. Method of measurement: Plain abdominal radiography. Duration of surgery. Timepoint: Time taken for PCNL. Method of measurement: Minute. Complications. Timepoint: Until the second day after surgery. Method of measurement: Physical examination. Hypothermia (axillary temperature below 35°C). Timepoint: Until the second day after surgery. Method of measurement: Thermometer. Length of hospitalization. Timepoint: Length of hospitalization. Method of measurement: Medical record. Oroumia University of Medical Sciences Approved 2023-09-13 Ethics Committee of Imam Khomeini University hospital- Urmia University of MedicalSciences Imam Khomeini hospital, Ershad Ave, Modarres Blvd, Urmia, Iran. Urmia West Azarbaijan Iran (Islamic Republic of)