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IRCT20180625040232N5 IRCT 2020-08-06 Shahid Beheshti University of Medical Sciences Evaluation of laparoscopic surgery success versus percutaneous surgery for kidney staghorn stone Comparison of Laparoscopic Pyelolithotomy versus Percutaneous Nephrolithotomy for the Treatment of patients with Staghorn Kidney Stones ; a randomized clinical trial 2020-04-03 anticipated 68 Complete https://irct.ir/trial/48258 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects; it means we will have 17 blocks. Then, within each block, subjects will be randomly assigned to laparoscopy or percutaneous procedure. Random assignment will be done using a random number table, Blinding description: Given that the surgical technique should be reported to patients preoperatively , the researcher and patients participating in the study should be aware of the surgical technique, but the analyst is unaware of which patient belongs to which intervention group. 3 Calculus of kidney. Intervention 1: Intervention group: Patients with one piece or maximum two piece Stag Horn Stone with extra renal pelvis who will undergo per-cutaneous nephrolithotomy. Intervention 2: Intervention group: Patients with one piece or maximum two piece Stag Horn Stone with extra renal pelvis who will undergo laparoscopic Pyelolithotomy. Yes - There is a plan to make this available What will be shared: Any information without the need for patients' names will be available When: Six months after publication To whom: Faculty members of medical universities Conditions: For research purposes Where to obtain: Email to Dr. Saman Farshid farshid.s@umsu.ac.ir How to obtain: Email to Dr. Saman Farshid farshid.s@umsu.ac.ir Comments:
public Saman Farshid
Imam Khomeini Hospital , Ershad Blvd ,Urmia
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3345 7287 samanf63@gmail.com Oroumia University of Medical Sciences scientific Saman Farshid
Imam Khomeini Hospital , Ershad Blvd ,Urmia
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3345 7287 samanf63@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients with One-Piece or Two-piece Stag-Horn Stone with large Extra-Renal part Absence Of active Urinary Tract Infection Absence Of coagulopathy Age 18-65 years old HB > 10 mg/dl ASA physical status classification 1 or 2 18 years 65 years Both Absence of consent for entering the study Absence of acceptance for the probability open surgery in each group of studies N20.0 Calculus of kidney Treatment - Surgery Treatment - Surgery Intervention group: Patients with one piece or maximum two piece Stag Horn Stone with extra renal pelvis who will undergo per-cutaneous nephrolithotomy Intervention group: Patients with one piece or maximum two piece Stag Horn Stone with extra renal pelvis who will undergo laparoscopic Pyelolithotomy Stone Free Rate. Timepoint: ِDuring Surgery , 2weeks after surgery in outpatient visit at hospital clinic. Method of measurement: Checklist. Pain severity after surgery. Timepoint: After surgery intervention during Admission. Method of measurement: According to Visual Analogue Scale Questionnaire. Hemoglobin Drop After Surgery. Timepoint: Before and after surgery intervention. Method of measurement: CBC-Diff Test before and after surgery. Surgery Time. Timepoint: During surgery intervention. Method of measurement: Recording the surgery time after anesthesia induction. Post Operation Complication. Timepoint: Post operation complication. Method of measurement: Complication Check list. Creatinine. Timepoint: Before and after surgery intervention. Method of measurement: Blood sampling. Number of hospitalized day. Timepoint: Once on the discharge time. Method of measurement: Patient's file. Shahid Beheshti University of Medical Sciences Approved 2019-06-20 ٍEthics committe of Shahid Labbafinejad Medical Center and Urology and Nephrology Research Center,Sh No103,9th Boostan Eslami Ave.,Pasdaran Blvd,Tehran Tehran Tehran Iran (Islamic Republic of)