]>
IRCT20171126037628N1 IRCT 2018-03-05 Shiraz University of Medical Sciences Using a new splitted Amplatz sheath in PCNL operation Comparison of using a newly designed splitted side Amplatz sheath and conventional Amplatz sheath in patients undergoing percutaneous nephrolithotomy in terms of surgical outcomes and complications 2018-02-20 anticipated 100 Complete https://irct.ir/trial/28435 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We randomly gathered our study samples from Patients above 18 years old with renal stone who wants to go under PCNL. Sample size is calculated as 100 patients based on a Type I error of 5%, statistical power 80%. Patients will be divided randomly into two groups, each containing 50 members by blocking randomization, Blinding description: Patients will be informed well about both technique though will not know by which method they will be operated. Also different physician will follow patients who will not know the type of operation. N/A renal stone. Intervention 1: Intervention group: Renal stone patients older than 18 years without exclusion criteria and will be gone under the PCNL surgery with newly designed splitted side Amplatz sheath. Intervention 2: Control group: Renal stone patients older than 18 years without exclusion criteria and will be gone under the PCNL surgery with conventional Amplatz sheath. Yes - There is a plan to make this available What will be shared: As long as we want to share the result of our study with other researchers we will write a paper that contain all the information about our study such as method, analysis, and results. Also if the journal or other researchers ask us to share our patients' data and their informed consent we are ready to share them. When: while our paper published To whom: All the researchers that prove they are researchers Conditions: Our data only can be used in other researches Where to obtain: By sending a request to first or corresponding author's email How to obtain: Researcher who needs our data must introduce his/her completely (including his/her name and family name, occupation, place of work, address) and introduce us two to three of his/her previous studies along with the request email Comments:
public Abdolreza Haghpanah
No. 7134844119, Shahid Faghihi hospital, Zand Ave, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3628 1563 haghpanahr@sums.ac.ir Shiraz University of Medical Sciences scientific Abdolreza Haghpanah
No. 7134844119, Shahid Faghihi hospital, Zand Ave, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3628 1563 haghpanahr@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients above 18 years old with renal stone who wants to go under PCNL 18 years no limit Both solitary kidney abnormal renal function. N20 Calculus of kidney and ureter Treatment - Surgery Treatment - Surgery Intervention group: Renal stone patients older than 18 years without exclusion criteria and will be gone under the PCNL surgery with newly designed splitted side Amplatz sheath Control group: Renal stone patients older than 18 years without exclusion criteria and will be gone under the PCNL surgery with conventional Amplatz sheath Operation time. Timepoint: one time after the procedure. Method of measurement: by lessen the time of initiation from end of surgery. Need for blood transfusion. Timepoint: during the surgery and admission days. Method of measurement: By reading operation and nursing note. Perirenal fluid collection. Timepoint: after surgery. Method of measurement: Sonography. Addmission duration. Timepoint: After admission. Method of measurement: Reading patient document. Post operation fever. Timepoint: after surgery. Method of measurement: thermometer. Residual stone size>5mm. Timepoint: One time after operation. Method of measurement: CT scan and Songography post operation. Particle extraction time. Timepoint: Once during operation. Method of measurement: Clock. Shiraz University of Medical Sciences Approved 2018-02-07 Ethics committee of Shiraz University of Medical Sciences Central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)