Effect of ARISTA Hemostatic Powder on Reduction of Complications after PCNL(Percutaneous Nephrolithonomy)Surgery
Design
Clinical trial with two parallel groups without blinding ,simple randomization
Settings and conduct
This clinical trial will be performed in Sina Hospital. Patients will be divided into control and intervention groups by simple randomization method. Before surgery, for all patients KUB will be performed. In the intervention group, after surgery, the Arista powder will be pumped into the amplutz before removal of the amplutz followed by its removal in the ampllutz route. This study was not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:A candidate for treatment in the form of PCNL
Exclusion criteria:Coagulation problems,Pregnant women
Intervention groups
1-Hemostatic Powder:The powder in the intervention group will be used to determine the extent of bleeding and surgical complications
2-No use of hemostatic powder :The control group will not use hemostatic powder
Main outcome variables
Evaluation of bleeding after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190624043991N2
Registration date:2019-09-07, 1398/06/16
Registration timing:registered_while_recruiting
Last update:2019-09-07, 1398/06/16
Update count:0
Registration date
2019-09-07, 1398/06/16
Registrant information
Name
Seyed Mohammad Kazem Aghamir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
mkaghamir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-06, 1398/06/15
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ARISTA Hemostatic Powder on Reduction of Complications after PCNL Surgery
Public title
Effectiveness of bleeding preventive powder for reducing postoperative PCNL complications
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for PCNL treatment
Exclusion criteria:
Patients with blood coagulation defects
Patients with acute urinary tract infections
Pregnant women
Very obese people
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method used in this study will be a simple randomization study that randomly selects a number using the random number table and moves to the right according to the previous assumption. If the number was even, the patient entered the intervention group and if Number of individual patients will enter the control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs-Tehran University of Mwdical Sciences
Street address
Emam Khomeini St,Hassan-abad Sq,Sina Hospital,Urology Research Center
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2019-06-24, 1398/04/03
Ethics committee reference number
IR.TUMS.VCR.REC.1398.347
Health conditions studied
1
Description of health condition studied
Urinary stones
ICD-10 code
N20.2
ICD-10 code description
Calculus of kidney with calculus of ureter
Primary outcomes
1
Description
Bleeding after surgery from the site of surgery
Timepoint
Immediately after surgery
Method of measurement
The number of wet gases
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Half of Patients undergoing PCNL surgery after the end of surgery and removal of stones and re-examination of the kidney with a nephroscope before removing the ampluvat of the hemostatic powder (3 grams with brand name (arista is pumped into the amplutz and accompanied by the exit of the amplutz in its path) The hemostatic powder is pumped
Category
Treatment - Drugs
2
Description
Half of patients will undergo PCNL surgery that will not receive ARISTA hemostatic powder after surgery.receive ARISTA after the surgery.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Behroz Fatahi
Street address
Emam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Email
mkaghamir@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad ali Sahraeian
Street address
Ghods St
City
Tehran
Province
Tehran
Postal code
1136746811
Phone
+98 21 8163 3627
Email
mkaghamir@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Farzaneh Bagherpour
Position
Colleague
Latest degree
Bachelor
Other areas of specialty/work
Laboratory Medicine
Street address
Emam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Email
farzaneh.bagherpoor@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed mohammad kazem Aghamir
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Emam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Email
mkaghamir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farzaneh.bagherpour
Position
Colleague
Latest degree
Bachelor
Other areas of specialty/work
Laboratory Medicine
Street address
Emam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Email
farzaneh.bagherpoor@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available