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IRCT20190624043991N12 IRCT 2020-11-28 Tehran University of Medical Sciences Minimally invasive Surgery Ureterolithotomy and Trans urethral Lithotripsy with Retrograde Internal Surgery A Comparison Between Minimally invasive Surgery Ureterolithotomy and Trans urethral Lithotripsy with Retrograde Internal Surgery 2020-08-05 anticipated 74 Complete https://irct.ir/trial/52581 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: The present study is a single-blind randomized clinical trial. For randomization, the blanced block randomization method is used to generate four blocks. Intervention group A and control group B have been determined.According to the randomization method, we expect the two groups to differ by a maximum of 2 people in terms of the number of people assigned. After the methodologist prepares the randomization sequence using the sealdenvelop online site, the generated sequence will be made available to a technician outside the research team.Quadruple blocks (A or B) are placed in envelopes. After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected and the type of patient group is informed to the research team through a trained technician.The patient is placed in (Minimally invasive Surgery Ureterolithotomy) or (Trans urethral Lithotripsy with Retrograde Internal Surgery) group based on the randomly selected envelope, Blinding description: Patients who have given their consent to participate in the study will be treated with Minimally invasive Surgery Ureterolithotomy or Trans urethral Lithotripsy with Retrograde Internal Surgery. The patient has no information about the surgical procedure and the design. N/A Urethral stone. Intervention 1: Intervention group: Minimally invasive Surgery Ureterolithotomy. Intervention 2: Intervention group: Trans urethral Lithotripsy with Retrograde Internal Surgery. Yes - There is a plan to make this available What will be shared: demographic information anonymously When: one year after publication To whom: Researchers working in academia, physicians, surgeons and hospitals Conditions: Any analysis can be done with the consent of the main researcher Where to obtain: Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560 How to obtain: After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy. Comments: -
public Dr Akram Mirzaei
Urology Research Center- Sina Hospital - Imam Khomeini St
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 mirzaee.scholar@gmail.com Tehran University of Medical Sciences scientific Dr Mohammad Kazem Aghamir
Urology Research Center- Sina Hospital - Imam Khomeini St
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 mkaghamir@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Consent to participate in the study Urinary stones larger than 15 mm no limit no limit Both Patients affected by hemorrhagic diseases Cases that have Systemic Inflammatory Response Syndrome untreated urinary tract infection N21 Calculus of lower urinary tract Treatment - Surgery Treatment - Surgery Intervention group: Minimally invasive Surgery Ureterolithotomy Intervention group: Trans urethral Lithotripsy with Retrograde Internal Surgery Treatment of urinary stones(Kidney stones). Timepoint: before and one month after surgery. Method of measurement: Spiral CT scan of the abdomen and pelvis, before and after surgery. Tehran University of Medical Sciences Approved 2020-08-03 Ethics Committee for Research in Tehran University of Medical Sciences Room 604, Sixth Floor, medical University Tehran, Central Staff Building, Keshavarz Blvd., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)