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IRCT20171228038115N1 IRCT 2018-05-25 Shahid Beheshti University of Medical Sciences Comparison of therapeutic outcomes and complications of Overnight stay versus ordinary admission (3 days) after Percutaneous Nephrolithotomy Comparison of therapeutic outcomes and complications of Overnight stay after Percutaneous Nephrolithotomy versus ordinary admission (3 days) in patients with renal stones: a randomized clinical trial 2013-04-21 anticipated 300 Complete https://irct.ir/trial/28636 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using block randomization method, the patients will be categorized into two groups. Each block contains 4 components named "A" and "B" representing two methods of interest. Based on the permutation of the words (A and B), six blocks are defined: 1: AABB 2: BBAA 3: ABBA 4: BAAB 5: ABAB 6: BABA. We will use numbers 1 to 6 from random numbers table to choose a block randomly. Numbers 0, 7, 8, and 9 will be ignored, Blinding description: The participant has no information about the time of discharge. 2 Stone Kidney. Intervention 1: Intervention group: In patients receiving general or spinal anesthesia, 5-French Ureteral Stent was placed on the affected side through cystoscopy. Then in dorsal lumbotomy position or supine position, pyelocaliceal system and stones were determined by contrast and fluoroscopy or ultrasonography, and a Chiba needle was passed into the selected calyces of the kidney. A guidewire was passed through the needle into the pelvis. Over the guidewire the dilatators and then working element (26-30F) were placed, and by using normal saline solution as irrigating solution, 24 French nephroscope was passed inside Amplatz sheaths and the stone(s) were crushed by pneumatic lithotripsy and removed with grasper. Finally, a nephrostomy tube was fixed in the kidney. The size of the nephrostomy tube was 20-24F depending on bleeding during the procedure,extent of manipulation, and surgeon’s preferences. If a considerable amount of the stone residue (>5mm) was observed on control fluoroscopy at the end of the procedure, the patient was excluded from the study. All the procedures were carried out by a surgeon.In group was discharged after extracting Foley catheter, ureter stent, and nephrostomy tub. Intervention 2: Control group: In patients receiving general or spinal anesthesia, 5-French Ureteral Stent was placed on the affected side through cystoscopy. Then in dorsal lumbotomy position or supine position, pyelocaliceal system and stones were determined by contrast and fluoroscopy or ultrasonography, and a Chiba needle was passed into the selected calyces of the kidney. A guidewire was passed through the needle into the pelvis. Over the guidewire. The dilatators and then working element (26-30F) were placed, and by using normal saline solution as irrigating solution, 24 French nephroscope was passed inside Amplatz sheaths and the stone(s) were crushed by pneumatic lithotripsy and removed with grasper. Finally, a nephrostomy tube was fixed in the kidney. The size of the nephrostomy tube was 20-24F depending on bleeding during the procedure, extent of manipulation, and surgeon’s preferences. If a considerable amount of the stone residue (>5mm) was observed on control fluoroscopy at the end of the procedure, the patient was excluded. The nephrostomy tube was removed on the second postoperative day. The patient was discharged on the third postoperative day after removing the Foley and the ureteral sten. Nephrostomy tube was extracted the day after surgery and the patient was discharged on the third postoperative day after extracting Foley catheter and ureter stent. 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 Needs to review
public Hormoz Karami
9th Boostan, Pasdaran St, Tehran Province
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2254 9039 r.bandari2314@yahoo.com Shahid Beheshti University of Medical Sciences scientific Hormoz Karami
9th Boostan, Pasdaran St, Tehran city
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2254 9039 r.bandari2314@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Acceptable anesthesia risk (ASA class< 3) No Single kidney or renal insufficiency No Pyonephrosis or infected stone Insignificant residual stone (<5mm) No intra or postoperative complications ≤ 1 unit blood transfusion during operation < 3 units hemoglobin decrease in the next morning 20 years 60 years Both Taking anti-coagulants UTI High creatinine Treatment - Surgery Treatment - Surgery Intervention group: In patients receiving general or spinal anesthesia, 5-French Ureteral Stent was placed on the affected side through cystoscopy. Then in dorsal lumbotomy position or supine position, pyelocaliceal system and stones were determined by contrast and fluoroscopy or ultrasonography, and a Chiba needle was passed into the selected calyces of the kidney. A guidewire was passed through the needle into the pelvis. Over the guidewire the dilatators and then working element (26-30F) were placed, and by using normal saline solution as irrigating solution, 24 French nephroscope was passed inside Amplatz sheaths and the stone(s) were crushed by pneumatic lithotripsy and removed with grasper. Finally, a nephrostomy tube was fixed in the kidney. The size of the nephrostomy tube was 20-24F depending on bleeding during the procedure,extent of manipulation, and surgeon’s preferences. If a considerable amount of the stone residue (>5mm) was observed on control fluoroscopy at the end of the procedure, the patient was excluded from the study. All the procedures were carried out by a surgeon.In group was discharged after extracting Foley catheter, ureter stent, and nephrostomy tub Control group: In patients receiving general or spinal anesthesia, 5-French Ureteral Stent was placed on the affected side through cystoscopy. Then in dorsal lumbotomy position or supine position, pyelocaliceal system and stones were determined by contrast and fluoroscopy or ultrasonography, and a Chiba needle was passed into the selected calyces of the kidney. A guidewire was passed through the needle into the pelvis. Over the guidewire. The dilatators and then working element (26-30F) were placed, and by using normal saline solution as irrigating solution, 24 French nephroscope was passed inside Amplatz sheaths and the stone(s) were crushed by pneumatic lithotripsy and removed with grasper. Finally, a nephrostomy tube was fixed in the kidney. The size of the nephrostomy tube was 20-24F depending on bleeding during the procedure, extent of manipulation, and surgeon’s preferences. If a considerable amount of the stone residue (>5mm) was observed on control fluoroscopy at the end of the procedure, the patient was excluded. The nephrostomy tube was removed on the second postoperative day. The patient was discharged on the third postoperative day after removing the Foley and the ureteral sten. Nephrostomy tube was extracted the day after surgery and the patient was discharged on the third postoperative day after extracting Foley catheter and ureter stent. Hemoglobin change. Timepoint: 1-3 days. Method of measurement: Blood test. Creatinine change. Timepoint: 1-3 days. Method of measurement: Blood test. Patients' non complicated discharge after one day. Timepoint: 1day. Method of measurement: Kidney, ureters and bladder x-ray (KUB), renal ultrasonography, checke hemoglobin (Hb) and creatinine (Cr), sodium and potassium . Fever. Timepoint: first 24 hour. Method of measurement: thermometer. Residual stone. Timepoint: first 24 hour. Method of measurement: Sonography. Shahid Beheshti University of Medical Sciences Approved 2013-03-12 Ethics committee of Shahid Beheshti University of Medical Sciences 9th Boostan ,Pasdaran St,Tehran. Tehran Tehran Iran (Islamic Republic of)