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IRCT20190624043991N24 IRCT 2023-12-09 Tehran University of Medical Sciences The effect of tattoo markers in marking the Bladder tumor site Evaluation of tattoo markers on marking the bladder tumor place for reTURBT :An Interventional Randomized Clinical Trial 2024-02-20 anticipated 20 Complete https://irct.ir/trial/74103 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, the balanced block randomization method is used to generate blocks with a size of 4. 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 available to a technician outside the research team. 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. Based on the randomly selected envelope, the patient is placed in the group (Patients who have markings with tattoo ink) or (Patients who do not have markings with tattoo ink), Blinding description: The present study is a single-blind, randomized clinical trial study. The participant will not know that he will be in the intervention group (Re TURBT candidate patients with tattoo ink) or the control group (Re TURBT candidate patients who do not have markings with tattoo ink). India ink or tattoo (an inert, colloidal suspension of carbon particles that has been used safely during colonoscopies for decades to mark the location of relevant lesions). N/A bladder tumor. Intervention 1: (Re-TURBT candidate patients who have tattoo ink marking for safe and successful marking of lesions in Re-TURBT patients with bladder tumor for the first time. Tattooing will be done at intervals of 1 to 2 cm, approximately 1 cm from the outer edge of the lesion, with sufficient depth (deep muscle layer) under cystoscopy guidance. Intervention 2: Control group: (Patients who are candidates for Re TURBT who do not have markings with tattoo ink). 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 mkaghamir@tums.ac.ir 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) Bladder tumor patients who were referred for the first time (primary). The size of the tumor is less than 3 cm The tumor is salitary Non metastatic tumor High grade tumor Informed consent from patients no limit no limit Both Multifocal tumor The volume of the patient's bladder should be small The tumor is recurrent The patient is not a candidate for reTURBT C67 Malignant neoplasm of bladder Diagnosis Diagnosis (Re-TURBT candidate patients who have tattoo ink marking for safe and successful marking of lesions in Re-TURBT patients with bladder tumor for the first time. Tattooing will be done at intervals of 1 to 2 cm, approximately 1 cm from the outer edge of the lesion, with sufficient depth (deep muscle layer) under cystoscopy guidance. Control group: (Patients who are candidates for Re TURBT who do not have markings with tattoo ink) Determining the success rate and feasibility of identifying the location of the tumor using of tattoo ink. Timepoint: Four to six weeks after TURBT. Method of measurement: The necessary pathological and cytological results (complete blood test, keratin, etc.). Tehran University of Medical Sciences Approved 2023-07-17 Research Ethics Committee, Sina Hospital Room 206, Ethics Committee Office، Second Floor, Administrative Building،Sina Hospital، Imam Khomeini Street,Tehran,Iran Tehran Tehran Iran (Islamic Republic of)