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IRCT2016041727426N2 IRCT 2016-05-25 Vice chancellor for research, Kerman university of medical sciaences Balloon dilation versus Amplatz dilation for ultrasound-guided percutaneous nephrolithotomy (PCNL) Randomized Clinical trail comparing Balloon dilation versus Amplatz dilation for ultrasound-guided percutaneous nephrolithotomy (PCNL) 2016-06-04 anticipated 60 Complete https://irct.ir/trial/22454 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 renal stone. Intervention 1: Amplatz group: In all patients, after access to the desired calyx with Chiba needle, a 0.035-inch J-tip guide wire will be placed in the system. Then the tract will be dilated up to 11 French using serial dilators. In this step in the first study group, Amplatz dilator will be used for tract dilatation.single use Amplatz and sheath from Boston scientific corporation will be used. Intervention 2: Baloon group: In all patients, after access to the desired calyx with Chiba needle, a 0.035-inch J-tip guide wire will be placed in the system. Then the tract will be dilated up to 11 French using serial dilators.then In the second study group, the tract will be dilated using balloon dilatator. Baloon dilator set with sheath 28 or 30 French sized from Boston Scientific corporation will be used.
public Dr Alinejad
Shahid Qarani St
Kerman Iran (Islamic Republic of) +98 34 3223 9188 mohsenalinejad40@yahoo.com Kerman university of medical sciences scientific Dr Hamid Pakmanesh
Shahid Bahonaar Hospital, Shahid Qarani St.
Kerman Iran (Islamic Republic of) +98 34 3223 9188 h_pakmanesh@kmu.ac.ir; h_pakmanesh@yahoo.com; pakmanesh@outlook.com Department of urology, Kerman university of medical sciences (KMU) Iran (Islamic Republic of) inclusion criteria: All patients including patients with staghorn; calyceal (in one or two calyces) or single pelvic stone who are candidate for PCNL are included. exclusion criteria: Patients with scattered stones in different calyxes will be excluded. no limit no limit Both N20.0 Calculus of kidney Treatment - Surgery Treatment - Surgery Amplatz group: In all patients, after access to the desired calyx with Chiba needle, a 0.035-inch J-tip guide wire will be placed in the system. Then the tract will be dilated up to 11 French using serial dilators. In this step in the first study group, Amplatz dilator will be used for tract dilatation.single use Amplatz and sheath from Boston scientific corporation will be used. Baloon group: In all patients, after access to the desired calyx with Chiba needle, a 0.035-inch J-tip guide wire will be placed in the system. Then the tract will be dilated up to 11 French using serial dilators.then In the second study group, the tract will be dilated using balloon dilatator. Baloon dilator set with sheath 28 or 30 French sized from Boston Scientific corporation will be used. Surgical complication. Timepoint: after surgery during one month period. Method of measurement: physician visit based on Clavien classification. Surgery duration. Timepoint: during surgery. Method of measurement: hour. Residual stone. Timepoint: the day after surgery. Method of measurement: sonography and radiology. Vice chancellor for research, Kerman university of medical sciaences Approved 2016-01-06 Ethics Committee of Kerman university of medical sciences Ebne sina st, Jahad st, Somayeh cross Kerman Iran (Islamic Republic of)