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IRCT20190528043745N1 IRCT 2019-11-16 Iran University of Medical Sciences Comparison of presence of detrusor muscle in pathology report between monopolar conventional TURBT and en-bloc TURBT en bloc TURB Comparison of presence of detrusor muscle in pathology report between monopolar conventional TURBT and en-bloc TURBT in bladder mass less than 3cm without past history of bladder mass in Hashemonejad hospital from 1396 to 1397 2017-08-23 anticipated 60 Complete https://irct.ir/trial/39885 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Other design features: no matter, Randomization description: Balance Blocked Randomization using statistical software, Blinding description: patient did not know about surgical technique. Pathologist did not know about surgical technique. Studied groups were introduced to analyzer as A and B groups. N/A Bladder mass. Intervention 1: Intervention group: This group is related to en bloc TURB surgery and includes 30 patients. In this procedure, patients underwent either general or spinal anesthesia under en bloc TURBT surgery using monopolar hooks and distilled water for intraoperative irrigation. Their pathological specimens are examined for the presence of detrusor muscle. After tumor resection, the tumor margin is coagulated about 0.5 cm away. Then, after fixing the three-way foley catheter, the bladder is washed with normal saline. Duration of surgery as well as postoperative complications including hemoglobin loss and bladder rupture were also studied. For all patients, 40 mg mitomycin is injected into the bladder for the first six hours after surgery. Intervention 2: control group: This group is related to conventional TURB surgery and includes 30 patients. In this procedure, patients underwent either general or spinal anesthesia under conventional TURBT surgery using monopolar loop and distilled water for intraoperative irrigation. Their pathological specimens are examined for the presence of detrusor muscle. After tumor resection, the tumor margin is coagulated about 0.5 cm away. Then, after fixing the three-way foley catheter, the bladder is washed with normal saline. Duration of surgery as well as postoperative complications including hemoglobin loss and bladder rupture were also studied. For all patients, 40 mg mitomycin is injected into the bladder for the first six hours after surgery. Yes - There is a plan to make this available What will be shared: All data can be published. When: After the paper publication To whom: All persons Conditions: under any circumstances Where to obtain: Ehsanzolfi1@gmail.com How to obtain: one weel Comments:
public Ehsan Zolfi
No 21, Namazi avenue, south Jannat abad,
Tehran Iran (Islamic Republic of) 1474746767 O098 21 46013954 ehsanzolfi1@gmail.com Iran University of Medical Sciences scientific Koosha Kamali
Vanak square, Hasheminejad hospital
Tehran Iran (Islamic Republic of) 1969714713 +98 21 8864 4457 kamali.k@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) mass less than 3cm no limit no limit Both past history of bladder mass C67 Malignant neoplasm of bladder Treatment - Surgery Treatment - Surgery Intervention group: This group is related to en bloc TURB surgery and includes 30 patients. In this procedure, patients underwent either general or spinal anesthesia under en bloc TURBT surgery using monopolar hooks and distilled water for intraoperative irrigation. Their pathological specimens are examined for the presence of detrusor muscle. After tumor resection, the tumor margin is coagulated about 0.5 cm away. Then, after fixing the three-way foley catheter, the bladder is washed with normal saline. Duration of surgery as well as postoperative complications including hemoglobin loss and bladder rupture were also studied. For all patients, 40 mg mitomycin is injected into the bladder for the first six hours after surgery. control group: This group is related to conventional TURB surgery and includes 30 patients. In this procedure, patients underwent either general or spinal anesthesia under conventional TURBT surgery using monopolar loop and distilled water for intraoperative irrigation. Their pathological specimens are examined for the presence of detrusor muscle. After tumor resection, the tumor margin is coagulated about 0.5 cm away. Then, after fixing the three-way foley catheter, the bladder is washed with normal saline. Duration of surgery as well as postoperative complications including hemoglobin loss and bladder rupture were also studied. For all patients, 40 mg mitomycin is injected into the bladder for the first six hours after surgery. The presence or absence of muscle tissue. Timepoint: Pathological report up to two weeks after surgery. Method of measurement: Use of a microscope by a pathologist. Hasheminejad hospital Approved 2017-10-08 Ethics committee of Iran University of Medical Sciences Hemmat highway Tehran Tehran Iran (Islamic Republic of)