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IRCT20210316050721N1 IRCT 2022-12-21 Iran University of Medical Sciences Comparison of standard Percutaneous Nephrolithotomy and low flouro Percutaneous Nephrolithotomy Comparison of Percutaneous nephrolithotomy results in standard method and low radiation method under fluoroscopic guide in a single blinded randomized study with two paralel groups 2022-12-22 anticipated 35 Complete https://irct.ir/trial/55059 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Baseline data will be obtained before randomization. Enrolled patients who provide informed consent will be block randomized (1:1) to an intervention or control arm using this site:(http://sealedenvelope.com) , Blinding description: Patients are anesthetized at the time of surgery and will therefore be blind to the study group. Results such as the amount of residual stones and complications will be reviewed by an uninformed resident of the study group. Allocation concealment is done by the head nurse before transfer to the operating room and is done without the knowledge of the researcher. N/A Renal stone. Intervention 1: Intervention group:The patient is first placed under general anesthesia and then in lithotomy posiotion , a 5 french(Fr) ureteral catheter inserted into the ureter of the desired side using a 8 Fr rigid urethroscope. The patient is then placed in the prone position. After the preb and drep , targeted calix is identified with fluoroscopy orientation of the line of puncture is performed using a triangulation technique. The C-arm is moved back and forth between 2 positions, that is 1 parallel and 1 oblique to the line of puncture. After the proper orientation of the line of puncture is obtained, ventilation is suspended in full expiration. Retrograde instillation of contrast dye allows collecting system opacification and distention. during continuous fluoroscopic radiation an 18 gauge needle is advanced toward the desired calix in the oblique position to gauge the depth of puncture. After accessing the pyelocaliceal system , a A0.038-inch hydrophilic nitinol wire is inserted. Aspiration of urine verifies proper caliceal puncture. after that with a single shot ray, the correct location of the guide wire is ensured. We measure the amount of needle entry and then enter the dilator 8 Fr using the needle size with the same angle and direction to the measured amount, then we check the correct location with a single shot ray.We measure input of the dilator and because the diameter of the primary dilator is more than the antenna, we gently slide the antenna on the guide wire based on the sense of touch and the size of The primary dilator and enter the system. Then insert the dilator 28 or 30 Fr according to the desired size and check its location again using single Shot Ray. Finally, we insert the Amplatz working sheath slowly according to the size difference with the last dilator, which there is no need to re-check its location. Finally, after confirming the correct entry into wanted pyelocaliceal system (by watching urine and fluid injected into the ureteral catheter), the patient undergoes PCNL using a 24 Fr nephroscope , otherwise, the location will be corrected again. Intervention 2: Control group:The patient is first placed under general anesthesia and then in lithotomy posiotion , a 5 french(Fr) ureteral catheter inserted into the ureter of the desired side using a 8 Fr rigid urethroscope. The patient is then placed in the prone position. After the preb and drep , targeted calix is identified with fluoroscopy orientation of the line of puncture is performed using a triangulation technique. The C-arm is moved back and forth between 2 positions, that is 1 parallel and 1 oblique to the line of puncture. After the proper orientation of the line of puncture is obtained, ventilation is suspended in full expiration. Retrograde instillation of contrast dye allows collecting system opacification and distention. An 18 gauge needle is advanced toward the desired calix in the oblique position to gauge the depth of puncture. Continuous fluoroscopic monitoring is performed to ensure that the needle maintains the proper trajectory . aspiration of urine verifies proper caliceal puncture. A0.038-inch hydrophilic nitinol wire is then passed through the needle and into the collecting system.after that with a single shot ray, the correct location of the guide wire is ensured.under fluoroscopic guidance an attempt is made to advance the glidewire down the ureter. An 8Fr fascial dilator is passed into the calix, followed by a 5Fr Cobra tipped angiographic catheter.then we gently slide the antenna on the guide wire and we check it with fluoroscopic guidance.Then insert the dilator 28 or 30 Fr according to Continuous fluoroscopic monitoring. An Amplatz working sheath is placed following dilator of the tract to 30Fr.Finally, after confirming the correct entry into wanted pyelocaliceal system (by watching urine and fluid injected into the ureteral catheter), the patient undergoes PCNL using a 24 Fr nephroscope , otherwise, the location will be corrected again. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No additional information
public Behnam Shakiba
Department of Urology, Firoozgar hospital, Behafarin St., Karimkhan Ave.
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 3001 shakiba.b@iums.ac.ir Iran University of Medical Sciences scientific Behnam Shakiba
Urology Department, Firoozgar Hospital, Behafarin St., Karimkhan Ave.
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 1301 shakiba.b@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Renal stones more than 2 Cm in diameter 18 years no limit Both more than one access tract for login to pyelocaliceal system Pepole with morbid obesity (BMI more than 39) Abnormal anatomy of kidney N20.0 Calculus of kidney Treatment - Surgery Treatment - Surgery Intervention group:The patient is first placed under general anesthesia and then in lithotomy posiotion , a 5 french(Fr) ureteral catheter inserted into the ureter of the desired side using a 8 Fr rigid urethroscope. The patient is then placed in the prone position. After the preb and drep , targeted calix is identified with fluoroscopy orientation of the line of puncture is performed using a triangulation technique. The C-arm is moved back and forth between 2 positions, that is 1 parallel and 1 oblique to the line of puncture. After the proper orientation of the line of puncture is obtained, ventilation is suspended in full expiration. Retrograde instillation of contrast dye allows collecting system opacification and distention. during continuous fluoroscopic radiation an 18 gauge needle is advanced toward the desired calix in the oblique position to gauge the depth of puncture. After accessing the pyelocaliceal system , a A0.038-inch hydrophilic nitinol wire is inserted. Aspiration of urine verifies proper caliceal puncture. after that with a single shot ray, the correct location of the guide wire is ensured. We measure the amount of needle entry and then enter the dilator 8 Fr using the needle size with the same angle and direction to the measured amount, then we check the correct location with a single shot ray.We measure input of the dilator and because the diameter of the primary dilator is more than the antenna, we gently slide the antenna on the guide wire based on the sense of touch and the size of The primary dilator and enter the system. Then insert the dilator 28 or 30 Fr according to the desired size and check its location again using single Shot Ray. Finally, we insert the Amplatz working sheath slowly according to the size difference with the last dilator, which there is no need to re-check its location. Finally, after confirming the correct entry into wanted pyelocaliceal system (by watching urine and fluid injected into the ureteral catheter), the patient undergoes PCNL using a 24 Fr nephroscope , otherwise, the location will be corrected again. Control group:The patient is first placed under general anesthesia and then in lithotomy posiotion , a 5 french(Fr) ureteral catheter inserted into the ureter of the desired side using a 8 Fr rigid urethroscope. The patient is then placed in the prone position. After the preb and drep , targeted calix is identified with fluoroscopy orientation of the line of puncture is performed using a triangulation technique. The C-arm is moved back and forth between 2 positions, that is 1 parallel and 1 oblique to the line of puncture. After the proper orientation of the line of puncture is obtained, ventilation is suspended in full expiration. Retrograde instillation of contrast dye allows collecting system opacification and distention. An 18 gauge needle is advanced toward the desired calix in the oblique position to gauge the depth of puncture. Continuous fluoroscopic monitoring is performed to ensure that the needle maintains the proper trajectory . aspiration of urine verifies proper caliceal puncture. A0.038-inch hydrophilic nitinol wire is then passed through the needle and into the collecting system.after that with a single shot ray, the correct location of the guide wire is ensured.under fluoroscopic guidance an attempt is made to advance the glidewire down the ureter. An 8Fr fascial dilator is passed into the calix, followed by a 5Fr Cobra tipped angiographic catheter.then we gently slide the antenna on the guide wire and we check it with fluoroscopic guidance.Then insert the dilator 28 or 30 Fr according to Continuous fluoroscopic monitoring. An Amplatz working sheath is placed following dilator of the tract to 30Fr.Finally, after confirming the correct entry into wanted pyelocaliceal system (by watching urine and fluid injected into the ureteral catheter), the patient undergoes PCNL using a 24 Fr nephroscope , otherwise, the location will be corrected again. X ray time during surgery. Timepoint: intra operation. Method of measurement: fluoroscopic time. Bleeding. Timepoint: Before intervention and day after surgery. Method of measurement: Hemoglobin. Stone free rate. Timepoint: 1 week after surgery. Method of measurement: CT Scan or sonography plus KUB. Duration of Percutaneous nephrolithotomy. Timepoint: During surgery. Method of measurement: minute. Dose of radiation. Timepoint: During surgery. Method of measurement: Microgray per minute. Time of getting acsses into renal pyelocaliceal system. Timepoint: During surgery. Method of measurement: minute. Gender. Timepoint: Befor surgery. Method of measurement: Female or male. Age. Timepoint: Befor surgery. Method of measurement: Number. Stone measurement. Timepoint: Befor surgery. Method of measurement: Centimeter(measured by Spiral abdomenopelvic CT scan without contrast). Renal stone location. Timepoint: Before surgery. Method of measurement: Superior, middle, inferior calyces or renal pelvic or mix of them. Body mass index. Timepoint: Before surgery. Method of measurement: Body mass divided by the square of the body height(Kg/m2). Complications of surgery. Timepoint: 1 weeks after surgery. Method of measurement: The Clavien-Dindo Classification. Iran University of Medical Sciences Approved 2021-09-25 Faculty of Medicine - Iran University of Medical Sciences (Research Ethics Committee) Hasheminejd Kidney Center, Vali-nejad Str., Vanak Sq. Vali-e-asr Boul Tehran Tehran Iran (Islamic Republic of)