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IRCT20200129046298N1 IRCT 2020-03-11 Kerman University of Medical Sciences Comparison of success rate and complications of transureteral lithotripsy for uncomplicated ureteral stones with or without safety guide wire Comparison of success rate and complications of transureteral lithotripsy for uncomplicated ureteral stones with or without safety guide wire 2020-03-15 anticipated 348 Complete https://irct.ir/trial/45574 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each patient is assigned to A or B group immediately prior to surgery by computer software that make one of letters A or B randomly. The researcher is unaware of the procedure assigned to each of A or B, Blinding description: Neither the patents nor the researcher and the data analyzer know the used surgical technique . N/A Calculus of ureter. Intervention 1: Intervention group: not using the safety guide wire before trans ureteral lithotripsy. In this group the Lithotripsy will be started as soon as the stone is spotted in endoscopy and no more manipulation is done. Intervention 2: Control group: using safety guide wire. In this group, as soon as the stone is reached, the safety weir is secured from the side of the stone through the ureter into the pelvis, then the endoscope is removed, and the ureteroscopy is performed again from the side of the wire to the location of the stone, and then the lithotripsy is performed. Yes - There is a plan to make this available What will be shared: All potential data can be shared after unidentificaton people When: Start of access period 6 months after printing results To whom: It will only be available to researchers working in academic and scientific institutions Conditions: All additional statistical analysis is permitted Where to obtain: Coordinate with Dr. Pakmanesh on the technical responsibility of the project How to obtain: After the agreement of Kerman University of Medical Sciences as the main sponsor of the project, datas will be available Comments:
public Reza Behzadi
Bahonar hospital- Gharani street
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 reza_behzadi@yahoo.com Kerman University of Medical Sciences scientific Dr. Hamid Pakmanesh
Bahonar hospital- Gharani street
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 h_pakmanesh@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) All male and female pateints Need to uretroscopy or TUL Age at least 20 years Willing to participate in this study 20 years no limit Both 1. Presence of fever or positive urine culture prior to surgery 2. History of ureteral trauma or ureteral re-implantation or open stone surgery in the same side 3. Patients with renal transplantation 4. History of severe immunodeficiency and coagulopathy 5. Circumstances that make safety wire insertion mandetory (ie. Ureteral severe edema, ureteral stricture, abnormal anatomy, stone street.) 6. History of radiotherapy N20.1 Calculus of ureter Treatment - Surgery Treatment - Surgery Intervention group: not using the safety guide wire before trans ureteral lithotripsy. In this group the Lithotripsy will be started as soon as the stone is spotted in endoscopy and no more manipulation is done Control group: using safety guide wire. In this group, as soon as the stone is reached, the safety weir is secured from the side of the stone through the ureter into the pelvis, then the endoscope is removed, and the ureteroscopy is performed again from the side of the wire to the location of the stone, and then the lithotripsy is performed. Pain after surgery. Timepoint: one day after surgery. Method of measurement: VAS ruler. Ureteral injury. Timepoint: In case of clinical suspicion of severe ureteral injury, an imaging scan is performed as soon as possible after surgery. Method of measurement: IVU imaging. Stone free rate. Timepoint: one day post surgery. Method of measurement: KUB or sonography imaging. Ureteral stent placement. Timepoint: immediately after surgery. Method of measurement: presence of ureteral edema or injury or stone residue. Post surgry fevers. Timepoint: Immediately after surgery until 10 days after surgery daily. Method of measurement: thermometer. Acute abdomen. Timepoint: from immediately after surgery until 10 days after surgury. Method of measurement: physical examination. Body mass index (BMI). Timepoint: before surgury. Method of measurement: from BMI formula. Stone size. Timepoint: before surgery. Method of measurement: based on imaging( sonography or CT scan). Stone location. Timepoint: before surgery. Method of measurement: ct scan or sonography. Surgical time. Timepoint: during surgery. Method of measurement: minutes. New ureteral stenosis. Timepoint: one month after surgery. Method of measurement: IVU. Kerman University of Medical Sciences Approved 2020-01-25 Ethics committee of Kerman University of Medical Sciences Gharani street, shahid bahonar hospital Kerman Kerman Iran (Islamic Republic of)