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IRCT20200905048625N1 IRCT 2020-09-14 Tehran University of Medical Sciences Access to kidney stones in PCNL surgery using two methods of 3D technology and X-ray fluoroscopy Percutaneous Nephrolithotomy (PCNL) Evaluation of access to kidney stones in patients candidate for PCNL surgery using 3D technology in comparison with X-ray Fluorescopy 2020-08-31 anticipated 48 Complete https://irct.ir/trial/50768 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: The present study is a double-blind randomized clinical trial. For randomization, the blanced block randomization method is used to generate four blocks. Intervention group A and control group B have been determined.According to the randomization method, we expect the two groups to differ by a maximum of 2 people in terms of the number of people assigned. After the methodologist prepares the randomization sequence using the sealedenvelope online site, the generated sequence will be made available to a technician outside the research team.Quadruple blocks (A or B) are placed in envelopes. After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected and the type of patient group is informed to the research team through a trained technician.The patient is placed in PCNL surgery using 3D technology or in X-ray Fluorescopy group based on the randomly selected envelope, Blinding description: Patients who have given their consent to participate in the study and Therapist To perform the blinding process, envelopes related to the type of intervention are provided only to the technician. The physician is not informed of the type of intervention (PCNL surgery using 3D technology or in X-ray Fluorescopy group) (to avoid bias). 3 kidney stones. Intervention 1: Intervention group: PCNL surgery using three-dimensional technology -After the initial examination, all patients will have a CT scan without contrast of the abdomen and pelvis to evaluate the condition of the kidney stones (including size, exact location, angle of position), pelvic position, general anatomy of the abdomen and kidneys. CT scan images of patients are entered into Mimix software and a three-dimensional model of the kidney is designed and drawn from CT scan images. Using a 3D digital printer, a three-dimensional model of a kidney, which also includes a kidney stone, is made accurately and in accordance with the actual size, and finally, it is provided to the surgeon. 3D model before PCNL operation by surgeon, examination and preoperative planning for proper access to the stone site, will be done before the actual operation. PCNL surgery will then be performed to treat kidney stones in patients. -Variables of age, sex, pre- and postoperative serum creatinine, pre- and postoperative blood hemoglobin, postoperative bleeding, post-operative blood transfusion need, total PCNL surgery time, stone access time and stone profile will be recorded. Intervention 2: Intervention group: PCNL surgery using X-ray fluoroscopy - PCNL is performed using X-ray fluoroscopy to remove kidney stones by making a small hole through the skin. -This procedure is usually performed under general anesthesia or spinal anesthesia.Technically, in the PCNL method, the needle is passed through the skin to the kidney.The position of the needle is followed by fluoroscopy. With the help of a needle, a guide wire is inserted into the kidney.The needle is then removed, and while the guide wire is still inside the pelvis, a nephroscope is inserted to remove small stones.If the stone is large, it must first be crushed using ultrasound probes and then the stone pieces removed. -Variables of age, sex, pre- and postoperative serum creatinine, pre- and postoperative blood hemoglobin, postoperative bleeding, post-operative blood transfusion need, total PCNL surgery time, stone access time and stone profile will be recorded. Yes - There is a plan to make this available What will be shared: demographic information anonymously When: one year after publication To whom: Researchers working in academia, physicians, surgeons and hospitals Conditions: Re-information for the purpose of clarification Using data by referring to the article's original Get permission from the author of the article and the presenter Where to obtain: Sina Hospital, Urology Research Center, Dr. Seyed Reza Hosseini 00982166348560 How to obtain: After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy. Comments: -
public Dr Akram Mirzaei
Urology Research Center- Sina Hospital - Imam Khomeini St
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 mirzaee.scholar@gmail.com Tehran University of Medical Sciences scientific Dr Seyed Reza Hosseini
Hassan Abad Asqu. Sina Hospital
تهران Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 srhoseini@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with kidney stones larger than 15 mm Indications for PCNL surgery 18 years 80 years Both Patient dissatisfaction with participation in the research project Existence of surgical contraindication or CT scan N21 Calculus of lower urinary tract Treatment - Surgery Treatment - Surgery Intervention group: PCNL surgery using three-dimensional technology -After the initial examination, all patients will have a CT scan without contrast of the abdomen and pelvis to evaluate the condition of the kidney stones (including size, exact location, angle of position), pelvic position, general anatomy of the abdomen and kidneys. CT scan images of patients are entered into Mimix software and a three-dimensional model of the kidney is designed and drawn from CT scan images. Using a 3D digital printer, a three-dimensional model of a kidney, which also includes a kidney stone, is made accurately and in accordance with the actual size, and finally, it is provided to the surgeon. 3D model before PCNL operation by surgeon, examination and preoperative planning for proper access to the stone site, will be done before the actual operation. PCNL surgery will then be performed to treat kidney stones in patients. -Variables of age, sex, pre- and postoperative serum creatinine, pre- and postoperative blood hemoglobin, postoperative bleeding, post-operative blood transfusion need, total PCNL surgery time, stone access time and stone profile will be recorded. Intervention group: PCNL surgery using X-ray fluoroscopy - PCNL is performed using X-ray fluoroscopy to remove kidney stones by making a small hole through the skin. -This procedure is usually performed under general anesthesia or spinal anesthesia.Technically, in the PCNL method, the needle is passed through the skin to the kidney.The position of the needle is followed by fluoroscopy. With the help of a needle, a guide wire is inserted into the kidney.The needle is then removed, and while the guide wire is still inside the pelvis, a nephroscope is inserted to remove small stones.If the stone is large, it must first be crushed using ultrasound probes and then the stone pieces removed. -Variables of age, sex, pre- and postoperative serum creatinine, pre- and postoperative blood hemoglobin, postoperative bleeding, post-operative blood transfusion need, total PCNL surgery time, stone access time and stone profile will be recorded. Kidney stone removal. Timepoint: once a month. Method of measurement: CT-scan. Tehran University of Medical Sciences Approved 2020-08-27 Ethics Committee for Research in Tehran University of Medical Sciences Room 604, Sixth Floor, medical University Tehran, Central Staff Building, Keshavarz Blvd., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)