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IRCT20100313003547N6 IRCT 2019-04-15 Shahid Beheshti University of Medical Sciences Effect of removing the double J stent without cystoscopy after kidney transplantation Randomized clinical trial comparing the effect of removing the double-J stent without cystoscopy with attaching it to Foley catheter after kidney transplantation 2016-03-01 anticipated 170 Complete https://irct.ir/trial/3639 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Kidney Transplantation. Intervention 1: In the intervention group, the double J stent is removed without flexible cystoscopy by attaching the Foley catheter to a double J stent during the operation. Intervention 2: Control group: In the control group, the double J stent is removed with the help of flexible or rigid cystoscopy in the operation room. No - There is not a plan to make this available Justification or reason for not sharing IPD is The study started before 2019
public Mohammad Nadjafi-Semnani
Ninth Boostan Ave.- Pasdaran St. Tehran
Tehran Iran (Islamic Republic of) 1666663111 +98 21 2258 8016 nadjafi@sbmu.ac.ir Shahid Labafinejad Medical Center, Shahid Beheshti Medical University scientific Mohammad Nadjafi-Semnani
Ninth Boostan Ave.- Pasdaran St. Tehran
Tehran Iran (Islamic Republic of) 1666663111 +98 21 2258 8016 nadjafi@sbmu.ac.ir Shahid Labafinejad Medical Center, Shahid Beheshti Medical University Iran (Islamic Republic of) Patients with age less than 76 years; Patients with age more than 15 years; All patients who are candidate for renal transplantation by surgeons in the Labbafinejad hospital. 16 years 75 years Both Neurogenic bladder History of surgery in urinary bladder History of bladder outlet obstruction by Benign Prostatic Hyperplasia (BPH) After revascularization and before ureteroneocystostomy if the surgeon feels that there is need for stent to be removed later than 7 days Multiple renal arteries urinary leak that warrant stent removal later than 7 days. Z94.0 Kidney transplant status Treatment - Devices Treatment - Devices In the intervention group, the double J stent is removed without flexible cystoscopy by attaching the Foley catheter to a double J stent during the operation. Control group: In the control group, the double J stent is removed with the help of flexible or rigid cystoscopy in the operation room. Major Urologic Complications (MUC) including urinary leak and ureteral obstruction. Timepoint: Nine months. After discharge, one a week for a month, then every other week for next tow months and then monthly patients will be seen in the clinic. Method of measurement: Urinary leak is defined clinicaly by urine leak through the surgical drain and is confiremd by measuring urine creatinine and by delayed DTPA radionucleic scan. Ureteral obstruction is defined by rising of serum creatinine and finding of obstruction in ultrasonography scan or ante-grade nephrostography. Creatinine level in serum. Timepoint: one month, 6 months and 12 months after kidney transplantation. Method of measurement: laboratory measurments. Pain experienced during the stent removal. Timepoint: At the stent removal time during first ten days of transplantation. Method of measurement: Pain is measured by visual analogue scale (VAS). The cost of treatment. Timepoint: Three weeks. Method of measurement: The cost of cystoscopy procedure for stent removal is confirmed by hospital administration. Shahid Beheshti University of Medical Sciences Approved 2017-02-13 Urology Nephrology Research Center- Shahid Beheshti Medical University Pasdaran St. - 9th Nostan St. Tehran Tehran Iran (Islamic Republic of)