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IRCT20220207053961N1 IRCT 2022-04-03 Oroumia University of Medical Sciences The effect of intravesical gemcitabine on prevention of recurrence in non-muscle-invasive bladder cancer Comparing the intravesical effect of gemcitabine with distilled water after trans urethral resection of tumor on prevention of recurrence in non-muscle-invasive bladder cancer 2022-05-20 anticipated 134 Complete https://irct.ir/trial/62367 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into distilled water and gemcitabine groups using simple randomization. So that, based on determining sample in each group, the letters A (distilled water) and B (gemcitabine) will be written on the cards and all the cards will be placed in an envelope. then patients will be assigned to A or B groups by picking up cards, Blinding description: The study will be conducted as a double-blind clinical trial. The patient and the researcher who will be evaluating the outcomes will be blind about the allocation of patients into distilled water or gemcitabine groups. Group names will be encoded with the A and B letters. 3 Bladder tumor. Intervention 1: Intervention group: At the end of the surgery, 2000 mg of gemcitabine will be dissolved in 100 ccs of normal saline and injected into the duct through a catheter and the catheter will be closed for 3 hours. Intervention 2: Control group: At the end of the surgery, a three-way catheter will be inserted and the bladder will be washed continuously with sterile distilled water for three hours. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of patient information
public Dr. Mohammad Sadri
Imam Khomeini hospital, Ershad street, Modarres Blvd., Urmia, Iran.
Urmia Iran (Islamic Republic of) 5715789397 +98 44 3345 7286 sadri.m@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Mohammad Sadri
Imam Khomeini hospital, Ershad street, Modarres Blvd., Urmia, Iran.
Urmia Iran (Islamic Republic of) 57157-89397 +98 44 3345 7286 sadri.m@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients with non-muscle-invasive bladder cancer Patients candidate of trans urethral resection of tumor (TURT) Tumor size less than or equal to 3 cm Low grade tumor on cystoscopy Diagnosed tumors in first time no limit no limit Both Frequent recurrence Tumor size above 3 cm C67 Malignant neoplasm of bladder Treatment - Other Treatment - Other Intervention group: At the end of the surgery, 2000 mg of gemcitabine will be dissolved in 100 ccs of normal saline and injected into the duct through a catheter and the catheter will be closed for 3 hours. Control group: At the end of the surgery, a three-way catheter will be inserted and the bladder will be washed continuously with sterile distilled water for three hours. Tumor size. Timepoint: Three and six months after surgery. Method of measurement: In millimeters on sonography. Tumor recurrence. Timepoint: Three and six months after surgery. Method of measurement: Having a recurrence based on sonography. Tumor site. Timepoint: Three and six months after surgery. Method of measurement: Sonography. Oroumia University of Medical Sciences Approved 2021-11-10 Ethics Committee of Urmia University of Medical Sciences Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran. Urmia West Azarbaijan Iran (Islamic Republic of)