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IRCT20151123025202N42 IRCT 2024-11-10 Hamedan University of Medical Sciences Effect of cellulose oxide powder on prostatectomy bleeding rate Investigating the effect of cellulose oxide powder on the amount of bleeding following simple open prostatectomy using the transvesical method 2024-11-21 anticipated 30 Complete https://irct.ir/trial/79967 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: We made 30 cards and write letter I (Intervention) on 15 and on the other 15 letter C (Control). Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the envelopes randomly will be selected and open it, based on selected letter (I or C) patients will be assigned to intervention (with cellulose oxide powder ) or control (without cellulose oxide powder), Blinding description: The person evaluating the outcome of bleeding and the patient will not know how to allocate the groups (intervention/control). 2-3 Benign prostate enlargement. Intervention 1: Intervention group: In the intervention group, in order to stop the blood in the surgical site, the amount of 5 grams of Ketohem powder will be pumped into the prostate fossa. Intervention 2: Control group: In the control group, bleeding will be controlled by the usual method (without the use of Ketohem powder), a 24F three-way Foley catheter is inserted, a Foley balloon is filled and traction is established. Yes - There is a plan to make this available What will be shared: All data can be shared except for authors names When: From 2026 onwards it is permissible To whom: Clinical professionals and Researchers in all fields Conditions: For treatment of patients and develop research and science Where to obtain: Correspond to the email address of the scientific responsible for the study How to obtain: Send and receive email Comments:
public Abbas Moradi
Shahid Fahmideh
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 0097 a.moradi@umsha.ac.ir Hamedan University of Medical Sciences scientific Abbas Moradi
Shahid Fahmideh
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 0557 a.moradi@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Having benign prostatic hyperplasia Candidate for simple open prostatectomy surgery Negative urine culture no limit no limit Male Prostate hyperplasia by cancer History of any previous surgery or intervention on the prostate (except prostate biopsy) Current use of anticoagulant and antiplatelet drugs History of genetic bleeding disorders D29.1 Benign neoplasm of prostate Prevention Prevention Intervention group: In the intervention group, in order to stop the blood in the surgical site, the amount of 5 grams of Ketohem powder will be pumped into the prostate fossa. Control group: In the control group, bleeding will be controlled by the usual method (without the use of Ketohem powder), a 24F three-way Foley catheter is inserted, a Foley balloon is filled and traction is established. Blood hemoglobin level. Timepoint: Before surgery, 24 and 48 hours after surgery. Method of measurement: blood test. Blood hematocrit. Timepoint: Before surgery, 24 and 48 hours after surgery. Method of measurement: blood test. The amount of transfusion required. Timepoint: Discharge time from the hospital. Method of measurement: Patient's medical record. Hamedan University of Medical Sciences Approved 2024-10-26 Ethics committee of Hamadan Univercity of Medical Science Shahid fahmideh Hamadan Hamadan Iran (Islamic Republic of)