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IRCT20190720044279N1 IRCT 2020-06-09 Iran University of Medical Sciences Comparison of the success and complications of emergency and elective ureteroscopy for treatment of ureteral stone A clinical trial comparing the success and complications of emergency and elective ureteroscopy for treatment of ureteral stones 2020-06-09 anticipated 300 Complete https://irct.ir/trial/41217 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to balance block randomization table prepared for 300 patient with statistical software, 150 patient will be in case and the rest will be in the control group randomly.If a patient is eligible for inclusion, it will be randomly assigned to the allocation group. The patient will then receive the appropriate treatment based on the allocation group type. However, given that the patient will be described as urgent treatment if placed in the immediate treatment group and excluded if not accepted. Random allocation will be used via minimization procedure where the initial allocation treatment (first 40 cases) is based on a table of random number, subsequent allocations (from patient 41 onward) are based on a minimization protocol that has a relatively equal sample size in the two groups. The data, will be entered in SPSS software and Minim program will be employed for the minimization of the clinical data. N/A Ureteral stone. Intervention 1: Intervention group:Includes patients in the immediate emergency ureteroscopic treatment who undergo ureteroscopy within 24 hours of ED visit. Intervention 2: Control group: includes patients receiving unsuccessful stone expulsive (plus analgesic) therapy for 3 to 4 weeks who will undergo ureteroscopic treatment then. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after hiding patient identity When: 18 month after article publication, data is available To whom: Only for researchers in universities and academic institutions Conditions: No other condition is needed Where to obtain: Moslem Pourakrami 00989133579530 mo.pourakrami@gmail.com How to obtain: After receiving an email based on the the need to access the data of his article,respond will be sent within 30 work days Comments:
public Pejman Shadpour
Hasheminejad Hospital., Valinejad Street., Vali-e-asr Ave., Vanak Squ
Tehran Iran (Islamic Republic of) 1471319697 +98 21 8864 4485 pshadpour@gmail.com Iran University of Medical Sciences scientific Pejman Shadpour
Hasheminejad Hospital., Valinejad Street., Vali-e-asr Ave., Vanak Squ
Tehran Iran (Islamic Republic of) 1471319697 +98 21 8864 4485 pshadpour@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) patients with acute renal colic who are over 15 years and under 80 years ureteral stone larger than 6 mm normal creatinine 15 years 80 years Both Kidney failure (GFR less than 30) Fever above 38 ° C single kidney A history of ureteral stricture Leukocytosis above 20,000 and definitive indications of immediate intervention according to the EAU guideline (associated with urinary tract infection, obstructive uropathy or anuria) aspirin and/or anti-coagulant drugs use N20.1 Calculus of ureter Treatment - Surgery Treatment - Surgery Intervention group:Includes patients in the immediate emergency ureteroscopic treatment who undergo ureteroscopy within 24 hours of ED visit. Control group: includes patients receiving unsuccessful stone expulsive (plus analgesic) therapy for 3 to 4 weeks who will undergo ureteroscopic treatment then Comparing the quality of life in emergency and elective ureteroscopy for treatment of ureteral stones. Timepoint: 3 weeks after emergency visit. Method of measurement: Quality of life EQ_5D scale and Visual analogue Scale. Comparing the loss of work days in emergency and elective ureteroscopy for treatment of ureteral stones. Timepoint: 3 weeks after emergency visit. Method of measurement: Ask from Patient. Iran University of Medical Sciences Approved 2020-04-25 Ethics committee of Iran University of Medical Sciences Tehran Hemmat Highway next to Milad Tower Tehran Tehran Iran (Islamic Republic of)