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IRCT20231127060199N1 IRCT 2024-01-15 Tabriz University of Medical Sciences Comparison of the complications of renal cysts with laparoscopic removal and percutaneous cyst drainage Comparison of the results and complications Laparoscopic removal of renal cysts with percutaneous drainage and sclerosing injections 2024-01-21 anticipated 80 Complete https://irct.ir/trial/74116 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two groups by last digit of the patient's file number . Even number for group laparoscopic removal of renal cysts and odd number for percutaneous drainage and sclerosing injections, Blinding description: After selecting study groups based on last digit of the patient's file number. 1 and 2 labels were assigned to the target group by the secretary. Then, the patients will be intervened by the researcher in the operating room in the case group. 2 Simple kidney cysts. Intervention 1: Intervention group: Intralesional Bleomycin Sclerotherapy: In patients in this group, injections are performed by one person and under ultrasound guide in the operating room and under general anesthesia. After a general examination of the cyst with examination and ultrasound in the operating room, first the fluid contents of the cysts are repeatedly emptied under the ultrasound guide by a 10 cc syringe and needle number 21. While the needle head is in the same place inside the cyst and the control is done by sono, the sclerosing substance is injected at the site. The required dose is 0.5 units per kilogram of body weight. The maximum amount of injection to prevent possible complications is 10 units of sclerosing material. Intervention 2: Intervention group: Renal cyst removal by laparoscopic surgery. Yes - There is a plan to make this available What will be shared: A portion of the data that represents the final outcome When: Access will be 6 months after the results are printed To whom: Urological specialists in coordination with the presenter Conditions: The use of data to improve patients' treatment processes is safe Where to obtain: The person responsible for updating study information How to obtain: Requesting data and study documents will be done by correspondence with the person responsible for updating the study information Comments:
public Mohsen Mohammad Rahimi
Urology Ward,Imam Reza Hospital, Golgasht St.,Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7054 mm.rahimi1357@gmail.com Tabriz University of Medical Sciences scientific Alireza Farshi
Urology Ward,Imam Reza Hospital, Golgasht St.,Tabriz,
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3337 6923 dr.ramezanireza70@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with a simple kidney cyst in the upper part of the kidney Patients with a simple kidney cyst with a size of more than 4 cm 30 years 65 years Both patients with polycystic kidney Patients with infectious renal cysts patients with cystic tumors Patients with coagulopathy N28.1 Cyst of kidney, acquired Treatment - Surgery Treatment - Surgery Intervention group: Intralesional Bleomycin Sclerotherapy: In patients in this group, injections are performed by one person and under ultrasound guide in the operating room and under general anesthesia. After a general examination of the cyst with examination and ultrasound in the operating room, first the fluid contents of the cysts are repeatedly emptied under the ultrasound guide by a 10 cc syringe and needle number 21. While the needle head is in the same place inside the cyst and the control is done by sono, the sclerosing substance is injected at the site. The required dose is 0.5 units per kilogram of body weight. The maximum amount of injection to prevent possible complications is 10 units of sclerosing material. Intervention group: Renal cyst removal by laparoscopic surgery Duration of intervention. Timepoint: From the start of surgery to the end of surgery. Method of measurement: period of time. Duration of admitted. Timepoint: From admission to discharge. Method of measurement: Hospitalization day. The rate of complications after the intervention. Timepoint: At 3th,6th months after surgery. Method of measurement: Physical examination. He recurrence rate of Kidney cyst. Timepoint: At 3th,6th months after surgery. Method of measurement: Physical examination. Tabriz University of Medical Sciences Approved 2023-06-12 Ethics Committee of Tabriz Medical School No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)