A new equipment protocol for sterilizing the infection system during PCNL percutaneous nephrolithotomy surgery
Design
The present study is a single-blind randomized clinical trial.
Settings and conduct
This clinical trial will be conducted in Sina Hospital on 50 patients. The patients will be divided into two groups: sterilization of the disease operating system during percutaneous nephrolithotomy surgery with 10cc of betadine 7.5 and sterilization of the infection system during percutaneous nephrolithotomy surgery with sterile water .The patient will not know which group they will be placed in. Also, the urology fellowship assistant will do betadine injection.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with indications for percutaneous nephrolithotomy surgery, Consent to participate in the study.
Exclusion criteria: Immunocompromised patients, Taking drugs that cause immunodeficiency, Patients with a family history of thyroid problems.
Intervention groups
Intervention group 1:Urinary system sterilization during surgery with 10cc of 7.5% betadine solution (PovidoneIodine solution 10% PEJHAN CHEMI 250ml), Once during washing.
Intervention group 2: Urinary system sterilization during surgery with 10cc sterile water, (Sterile water, free of DNase and RNase, Acell Teb Rad MED), Once during washing.
Main outcome variables
post-surgical infections
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200905048625N3
Registration date:2024-02-05, 1402/11/16
Registration timing:prospective
Last update:2024-02-05, 1402/11/16
Update count:0
Registration date
2024-02-05, 1402/11/16
Registrant information
Name
seyed reza hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
srhoseini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-13, 1403/01/25
Expected recruitment end date
2025-03-10, 1403/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A new washing protocol to sterilize the urinary system during percutaneous nephrolithotomy surgery
Public title
A new washing protocol to sterilize the urinary system
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with indications for percutaneous nephrolithotomy surgery
Consent to participate in the study
Exclusion criteria:
Immunocompromised patients
Taking drugs that cause immunodeficiency
Patients with a family history of thyroid problems
Age
From 17 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a single -blind, randomized clinical trial study.
After random sequencing by the methodologist using the sealed envelope online site, the constructed sequence will be provided to a technician outside the research team. Blocks of four (A or B) are placed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study is a single-blind clinical trial study in which the patients are not informed about the type of intervention. The patient does not know whether he is in the intervention or control group due to being unconscious, and he cannot be informed about it in any way after the surgery.
Blood culture, urine culture, ESR, CRP, CBC, and body temperature measurement
Secondary outcomes
1
Description
Sodium measurement
Timepoint
24 and 48 hours after the operation
Method of measurement
Biochemical test-Sodium assay kit
2
Description
Potassium measurement
Timepoint
24 and 48 hours after the operation
Method of measurement
Biochemical test-Potassium assay kit
3
Description
Chloride measurement
Timepoint
24 and 48 hours after the operation
Method of measurement
Biochemical test-Chlorine test kit
Intervention groups
1
Description
Intervention group: Urinary system sterilization during percutaneous nephrolithotomy surgery with 10cc of 7.5% betadine solution (PovidoneIodine solution 10% PEJHAN CHEMI 250ml), Once during washing.
Category
Treatment - Other
2
Description
Control group: Urinary system sterilization during percutaneous nephrolithotomy surgery with 10cc sterile water, (Sterile water, free of DNase and RNase, Acell Teb Rad MED), Once during washing.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Seyed Reza Hosseini
Street address
Urology Research Center, Sina Hospital, Hassan Abad
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
srhoseini@tums.ac.ir
Web page address
http://sinahospital.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Sixth Floor, Central University, Quds Ave., Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
http://vcr.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
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Seyed Reza Hosseini
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8560
Email
srhoseini@tums.ac.ir
Web page address
https://URC@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
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
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demographic information anonymously
When the data will become available and for how long
One year after publication
To whom data/document is available
Researchers working in academia, physicians, surgeons and hospitals
Under which criteria data/document could be used
Any analysis can be done with the consent of the main researcher
From where data/document is obtainable
Sina Hospital, Urology Research Center, Dr. Seyed Reza Hosseini 00982166348560
What processes are involved for a request to access data/document
After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy.