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IRCT20201218049752N1 IRCT 2022-01-10 Iran University of Medical Sciences Effectiveness of limiting unwanted movementes of Amplatz during PCNL Evaluation of the effectiveness of limiting unwanted movementes of Amplatz during percutaneous nephrolithotomy(PCNL) in reducing bleeding 2021-11-21 anticipated 100 Complete https://irct.ir/trial/60214 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balanced-Blocked Randomization was down with quadruple blocks by epidemiologist by using Statistical software .Randomization table was provided to the project manager.According to the randomization table in the operating room, the project manager puts patients in two intervention or control groups and records the information confidentially. The facilitator provides patient information to the statistical analyzer without mentioning the identities of the individuals, Blinding description: The facilitator gives a comprehensive explanation to all patients who enter the study about the type of interventions and their possible consequences, but by the end of the study, the patient does not know whether he is in the intervention group or not. During the hospitalization, the patient nurse does not know the identity of the patients in the intervention or control group. According to the randomization table in the operating room, the project manager places the patients in the intervention or control group and records the information.The total information recorded is provided to the analyzer in the form of numbers and without the patient's identity. N/A Calculus of kidney. Intervention 1: Control group: First, with the help of a retrograde fluoroscope and pyelography, insert a special needle and then a guidewire into the kidney, make an incision of about one centimeter on the skin and dilate the skin-to-kidney route to 30 French. In the next step, a plastic tube called Amplatz is guided on the dilator into the kidney.Then the dilator is removed and the Amplatz remains to the end of the operation.Then, stone crushing is performed with a nephroscope and lithoclast.Then the stone pieces are removed through the Amplatz.At the end of the operation, the tube is removed and the skin defect is sutured. Intervention 2: Intervention group:First, with the help of a retrograde fluoroscope and pyelography, insert a special needle and then a guidewire into the kidney.Make an incision of about one centimeter on the skin. We pass the needle and suture (In the control group, it was performed at the end of the operation) through the skin defect without tying.Then we dilate the skin to kidney route up to 30 French. In the next step, a plastic tube called Amplatz is guided on the dilator into the kidney.Then the dilator is removed and the Amplatz remains.Mount a screw ring clamp on the Amplatz and tie the thread through the skin defect around it so that the Amplatz is fixed to the skin.By tightening or loosening the screw, it is possible to stabilize or release the Amplatz.Stone crushing is performed with a nephroscope and lithoclast.Then the stone pieces are removed through the Amplatz.At the end of the operation, the suture knot is untied from the Amplatz, so it removed and the suture is tied at the site of the skin defect. 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 There is no further information
public Reza Elmimehr
Hosheminejad Hospital, Vali-nejad Str, Vank Sq, Vali-e-asr St
Tehran Iran (Islamic Republic of) 1969714713 +98 21 81161 r.elmimehr57@gmail.com Iran University of Medical Sciences scientific Reza Elmimehr
Hasheminejad Hospital, Vali-nejad Str, Vanak Sq, Vali-e-ase Boul
Tehran Iran (Islamic Republic of) 1969714713 +98 21 81161 r.elmimehr57@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients older than 18 years who have kidney stones with indication for removal of kidney stones through the skin 18 years no limit Both N20.0 Calculus of kidney Treatment - Surgery Treatment - Devices Control group: First, with the help of a retrograde fluoroscope and pyelography, insert a special needle and then a guidewire into the kidney, make an incision of about one centimeter on the skin and dilate the skin-to-kidney route to 30 French. In the next step, a plastic tube called Amplatz is guided on the dilator into the kidney.Then the dilator is removed and the Amplatz remains to the end of the operation.Then, stone crushing is performed with a nephroscope and lithoclast.Then the stone pieces are removed through the Amplatz.At the end of the operation, the tube is removed and the skin defect is sutured. Intervention group:First, with the help of a retrograde fluoroscope and pyelography, insert a special needle and then a guidewire into the kidney.Make an incision of about one centimeter on the skin. We pass the needle and suture (In the control group, it was performed at the end of the operation) through the skin defect without tying.Then we dilate the skin to kidney route up to 30 French. In the next step, a plastic tube called Amplatz is guided on the dilator into the kidney.Then the dilator is removed and the Amplatz remains.Mount a screw ring clamp on the Amplatz and tie the thread through the skin defect around it so that the Amplatz is fixed to the skin.By tightening or loosening the screw, it is possible to stabilize or release the Amplatz.Stone crushing is performed with a nephroscope and lithoclast.Then the stone pieces are removed through the Amplatz.At the end of the operation, the suture knot is untied from the Amplatz, so it removed and the suture is tied at the site of the skin defect. Hemoglobin changes. Timepoint: Measurement of patient hemoglobin in miligram per deciliter the day before surgery and 6 and 24 hours after surgery. Method of measurement: Laboratory. Amplatz position. Timepoint: during surgery. Method of measurement: questionnaire. Duration of operation. Timepoint: The number of minutes elapsed from the beginning to the end of the operation. Method of measurement: Patient file. Iran University of Medical Sciences Approved 2021-10-31 Ethics Committee of Iran University of Medical Sciences Hasheminejad hospital, Vali-nejad Str, Vanak Sq, Vali-e-asr Str Tehran Tehran Iran (Islamic Republic of)