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IRCT20190618043925N1 IRCT 2019-07-18 Tehran University of Medical Sciences Investigation the effect of hemoglobin drop in kidney stone disease surgery Comparison of hemoglobin drop after tubeless percoutaneous nephrolithotomy with flank compression on 0,3,7 minutes, aclinical trial 2019-07-28 anticipated 60 Complete https://irct.ir/trial/40546 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Individual simple randomized and systematic: Samples were randomly assigned to two groups by using binary blocking and randomly assigned to three groups of compression for zero (as control group), three, and seven minutes using random numbered tables prepared by the researcher. A random number table is prepared by a design consultant and is provided to the researcher in closed envelopes. Once the envelope has been completed, the envelope is opened and the duration of the flank compression is determined, the same time compression of abdominal flank area is done by the surgeon or assistant. Sampling is performed from the beginning of the study successively from all eligible patients. Random instrument: sealed envelope, randomized tables prepared by the researcher, data entered into SPSS software and ANOVA test to compare the amount of bleeding. N/A Condition 1: Kidney stone larger than 2 centimeters. Condition 2: Extracorporeal Shock Wave Lithotripsy (ESWL)-resistant kidney stones. Condition 3: Minor calyces stones larger than 1 centimeter and upper ureter stones larger than 1 centimeter. Condition 4: Cystine stones stone size with 1.5 centimeter. Intervention 1: Control group: People who undergo kidney stone surgery through the skin due to kidney stones (the standard practice of percutaneous nephrolithotomy, PCNL) are examined.If the surgery finishes with tubeless method then the patients eligible to enter to the study and randomly assigned to three groups of compression of the flank-abdomen with the surgeon's hands for zero, three and seven minutes to control bleeding. The group which undergo the percutaneous nephrolithotomy surgery without insertion of nephrostomy tube and without any flank-abdominal compression is considered as a control group. Intervention 2: First intervention group: The persons who have 3 minutes flank compression on abdominal area after finishing tubeless percoutaneous nephrolithotomy surgery for control bleeding . Intervention 3: Second intervention group: the persons who have 7 minutes flank compression on abdominal area after finishing tubeless percoutaneous nephrolithotomy surgery for control bleeding . Intervention 4: Third intervention group: the persons who have between 3 and 7 minutes flank compression on abdominal area after finishing tubeless percoutaneous nephrolithotomy surgery for control bleeding . 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 more information
public Robab Maghsoudi
No 402, 4th floor, Sina building, Vali nejad Ave, Valiasr St, Vanak Sq
Tehran Iran (Islamic Republic of) 1969714713 +98 21 8865 8602 Maghsoudi.R@iums.ac.ir Tehran University of Medical Sciences scientific Robab Maghsoudi
No 402,4th floor, Sina building, Vali nejad Ave, Vanak Sq, Valiasr St
Tehran Iran (Islamic Republic of) 1969714713 +98 21 8865 8602 Maghsoudi.R@iums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) The patients who have kidney stone and are eligible for percoutaneous nephrolithotomy (PCNL) surgery 18 Age and above Being in the (American Society of Anesthesiologists 1,2) ASA 1,2 group for anesthetic risk 18 years no limit Both Patients with stones in the kidney have anatomical anomalies (malformation, pelvic kidney, horseshoe kidney) With BMI more than 30 Untreated coagulation disorder Taking aspirin during last 7 days Taking (Nonsteroidal Anti-inflammatory Drug) NSAID drugs during last 5 days Untreated urinary tract infection Severe pulmonary disease or other conditions that, according to an anesthetist, may not be pressure on the ipsilateral abdomen. N20.2 N20.0 N21.9 N21.1 Calculus of kidney with calculus of ureter Calculus of kidney Calculus of lower urinary tract, unspecified Calculus in urethra Treatment - Surgery Treatment - Surgery Treatment - Surgery Treatment - Surgery Control group: People who undergo kidney stone surgery through the skin due to kidney stones (the standard practice of percutaneous nephrolithotomy, PCNL) are examined.If the surgery finishes with tubeless method then the patients eligible to enter to the study and randomly assigned to three groups of compression of the flank-abdomen with the surgeon's hands for zero, three and seven minutes to control bleeding. The group which undergo the percutaneous nephrolithotomy surgery without insertion of nephrostomy tube and without any flank-abdominal compression is considered as a control group. First intervention group: The persons who have 3 minutes flank compression on abdominal area after finishing tubeless percoutaneous nephrolithotomy surgery for control bleeding . Second intervention group: the persons who have 7 minutes flank compression on abdominal area after finishing tubeless percoutaneous nephrolithotomy surgery for control bleeding . Third intervention group: the persons who have between 3 and 7 minutes flank compression on abdominal area after finishing tubeless percoutaneous nephrolithotomy surgery for control bleeding . Access place. Timepoint: Before starting the intervention. Method of measurement: Radiography. Kidney stone size. Timepoint: Before the intervention begins, multiply the largest diameter in the width of the stone. Method of measurement: Spiral CT abdomen and pelvis. Experience of open kidney stone surgery. Timepoint: A day before starting the intervention. Method of measurement: Questionnaire and medical evidence. Experience of percoutaneous nephrolithotomy surgery. Timepoint: A day before starting intervention. Method of measurement: Medical evidence and questionnaire. Diabetic. Timepoint: A day before the intervention. Method of measurement: Medical evidence. Patient weight. Timepoint: A day before the intervention. Method of measurement: Questionnaire. Height. Timepoint: A day before the intervention. Method of measurement: Questionnaire. Medicine consumption. Timepoint: A day before the intervention. Method of measurement: Questionnaire. Gender (male, female). Timepoint: A day before the intervention. Method of measurement: Questionnaire. Duration of surgery. Timepoint: Before starting the intervention according to evaluation access for taking out the amplatz. Method of measurement: chornometer. Creatinine. Timepoint: Measuring the creatinine a day before starting the intervention. Method of measurement: Laboratory analyzer. Amount of creatinine. Timepoint: Measuring creatinine a day after the intervention. Method of measurement: Laboratory analyzer. Hemoglobin. Timepoint: On the first day after the intervention in those who have abdominal flank compression . Method of measurement: Laboratory Analyzer. Hemoglobin. Timepoint: On the second day after the intervention in those who have abdominal flank compression . Method of measurement: Laboratory Analyzer. Flank's compression time. Timepoint: After starting the intervention. Method of measurement: Chronometer. Age. Timepoint: A day before the percoutaneous nephrolithotomy surgery. Method of measurement: Questionnaire. The transfused blood. Timepoint: Before the intervention and 24 hours after the surgery. Method of measurement: 3 liters blood in one third, two thirds serum in the operating room by section nurse. Tehran University of Medical Sciences Approved 2019-03-16 National Ethics Committee for Biomedical Research 5th floor, Shahid Hemmat West Highway between the intersection of Sheikh Fazlollah and Shahid Chamran ,Iran University of Medical Sciences, Tehran Tehran Tehran Iran (Islamic Republic of)