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IRCT20150420021869N2 IRCT 2019-05-21 Esfahan University of Medical Sciences LigaSure versus Stapling Device for Ligation of Bladder Pedicle on Erectile Function after Nerve Sparing Radical Cystectomy LigaSure versus Stapling Device for Ligation of Bladder Pedicle on Erectile Function after Nerve Sparing Radical Cystectomy 2018-01-21 anticipated 64 Complete https://irct.ir/trial/38445 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly divided into two groups. Simple randomization was performed. Randomization unit was individual. For allocation of the participants, a computer-generated list of random numbers was used. Since patients underwent general anesthesia, they were not aware of the device being used for ligating posterior bladder pedicle. Blinding of the surgeon was not feasible. Data regarding erectile function before and after the surgery was collected and analyzed by researchers blinded to the intervention performed, Blinding description: The patients were unaware of how the posterior bladder pedicle is closed. The researcher was blinded to the procedure by which the precipitants was underwent. The main surgeon was aware of the method of pedicle closure and blinding was not feasible. N/A Condition 1: Bladder cancer. Condition 2: Erectile dysfunction. Intervention 1: In this group, endo GIA stapling device was used to ligate bladder vascular pedicles. After developing plane between rectum and bladder at posterior aspect and freeing retzius space at lateral aspects, bladder pedicles are exposed and ligated using 60 mm endo GIA stapling device, which is a non-absorbable stapler. The only difference between two intervention groups is the technique of bladder pedicle ligation. Intervention 2: In this group, LigaSure was used to ligate bladder vascular pedicles. After developing plane between rectum and bladder at posterior aspect and freeing retzius space at lateral aspects, bladder pedicles are exposed and ligated using LigaSure, which is a bipolar electrocoagulation system. The only difference between two intervention groups is the technique of bladder pedicle ligation. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more data
public Farshad Gholipourr
Mardavij
Isfahan Iran (Islamic Republic of) 8168814193 +98 31 3669 7898 f-gholipour@student.tums.ac.ir Esfahan University of Medical Sciences scientific Farshad Gholipourr
Mardavij
Isfahan Iran (Islamic Republic of) 8168814193 +98 31 3669 7898 f-gholipour@student.tums.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) male patients younger than 70 years suffering muscle invasive bladder cancer candidate for radical cystectomy with orthotropic urinary diversion no limit 70 years Male patients with severe erectile dysfunction C67 N52 Malignant neoplasm of bladder Male erectile dysfunction Treatment - Surgery Treatment - Surgery In this group, endo GIA stapling device was used to ligate bladder vascular pedicles. After developing plane between rectum and bladder at posterior aspect and freeing retzius space at lateral aspects, bladder pedicles are exposed and ligated using 60 mm endo GIA stapling device, which is a non-absorbable stapler. The only difference between two intervention groups is the technique of bladder pedicle ligation. In this group, LigaSure was used to ligate bladder vascular pedicles. After developing plane between rectum and bladder at posterior aspect and freeing retzius space at lateral aspects, bladder pedicles are exposed and ligated using LigaSure, which is a bipolar electrocoagulation system. The only difference between two intervention groups is the technique of bladder pedicle ligation. Erectile function score in International Index of Erectile Function (IIEF) questionnaire. Timepoint: Before intervention, 6 and 12 months after intervention. Method of measurement: International Index of Erectile Function (IIEF). Esfahan University of Medical Sciences Approved 2016-09-27 Ethics committee of Isfahan University of Medical Sciences Hezarjarib St. Isfahan Isfehan Iran (Islamic Republic of)