Determining the effect of cellulose oxide powder on the amount of bleeding following simple open prostatectomy by transvesical method
Design
A clinical trial with a control group, with parallel groups, double-blind, phase 2-3 on 30 patients. Excel's rand function will be used for randomization.
Settings and conduct
This clinical trial will be conducted in Shahid Beheshti Hospital affiliated to Hamedan University of Medical Sciences on patients with benign prostate enlargement and candidates for open prostatectomy. Transvesical prostatectomy will be performed with spinal anesthesia. Patients will be under spinal anesthesia using 2.5-4 cc bupivacaine. Then they will be placed in the lithotomy position. prostatectomy is performed using the Freire technique. The patient and the outcome assessor will be blind of the method used to control bleeding (double-blind).
Participants/Inclusion and exclusion criteria
Criteria for entering the study: suffering from benign prostate enlargement, candidate for simple open prostatectomy, negative urine culture. Criteria for not entering the study: malignant prostate size, 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, severe increase in blood pressure during surgery, occurrence of complications during surgery Surgery such as capsule rupture or bladder injury
Intervention groups
After transvesical prostatectomy using the Freire technique, in order to stop the blood in the surgical site, the amount of 5 grams of Ketohem powder (Parsa Teb Company, Iran) will be pumped into the prostate fossa.
Main outcome variables
control of bleeding after surgery; Reducing the need for transfusion, reducing the drop in hemoglobin and hematocrit
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N42
Registration date:2024-11-10, 1403/08/20
Registration timing:prospective
Last update:2024-11-10, 1403/08/20
Update count:0
Registration date
2024-11-10, 1403/08/20
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-08-22, 1404/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of cellulose oxide powder on the amount of bleeding following simple open prostatectomy using the transvesical method
Public title
Effect of cellulose oxide powder on prostatectomy bleeding rate
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having benign prostatic hyperplasia
Candidate for simple open prostatectomy surgery
Negative urine culture
Exclusion criteria:
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
Age
No age limit
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
Blinding description
The person evaluating the outcome of bleeding and the patient will not know how to allocate the groups (intervention/control).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan Univercity of Medical Science
Street address
Shahid fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2024-10-26, 1403/08/05
Ethics committee reference number
IR.UMSHA.REC.1403.518
Health conditions studied
1
Description of health condition studied
Benign prostate enlargement
ICD-10 code
D29.1
ICD-10 code description
Benign neoplasm of prostate
Primary outcomes
1
Description
Blood hemoglobin level
Timepoint
Before surgery, 24 and 48 hours after surgery
Method of measurement
blood test
2
Description
Blood hematocrit
Timepoint
Before surgery, 24 and 48 hours after surgery
Method of measurement
blood test
Secondary outcomes
1
Description
The amount of transfusion required
Timepoint
Discharge time from the hospital
Method of measurement
Patient's medical record
Intervention groups
1
Description
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.
Category
Prevention
2
Description
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.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Mohsen Alemi
Street address
Eram Blv, Ghaem Sq, Hamedan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 3838 0283
Email
Shahidbeheshti@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohi
Street address
Shahid Fahmide Ave
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data can be shared except for authors names
When the data will become available and for how long
From 2026 onwards it is permissible
To whom data/document is available
Clinical professionals and Researchers in all fields
Under which criteria data/document could be used
For treatment of patients and develop research and science
From where data/document is obtainable
Correspond to the email address of the scientific responsible for the study
What processes are involved for a request to access data/document