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Investigating the effect of antibiotics in washing fluid on inflammatory factors during and after transurethral lithotripsy: a single blind clinical trial

Protocol summary

Study aim
Investigating the effect of antibiotics in washing fluid on inflammatory factors during and after transurethral lithotripsy: a single blind clinical trial
Design
The study is interventional in two control groups (40 people) and intervention (40 people), single-blind , phase 3, parallel and therapeutic.
Settings and conduct
This clinical trial will be conducted in Sinai Hospital, Urology Research Center, on 80 patients. Group A: - Control group: 0.9% standard saline serum B: Intervention group: 1000 mg ceftriaxone antibiotic + 6 liters of 0.9% normal saline.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness and informed consent of the patient, age between 20 and 70 years, elective surgery, stones smaller than 20 mm in the upper middle ureter. Exclusion criteria: previous history of urinary system surgery, concurrent kidney stones, bilateral ureteral stones, anatomical disorders، positive urine culture before surgery, use of corticosteroids or antibiotics before surgery, immunodeficiency , diabetes
Intervention groups
Control group: normal saline serum 0.9% Intervention group: 1000 mg ceftriaxone antibiotic + 6 liters of normal saline 0.9%
Main outcome variables
Reducing the possibility of post-surgery infections, treatment costs, morbidity, and mortality due to this surgery and no effect on the gastrointestinal microbiome.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190624043991N20
Registration date: 2023-09-25, 1402/07/03
Registration timing: prospective

Last update: 2023-09-25, 1402/07/03
Update count: 0
Registration date
2023-09-25, 1402/07/03
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
2024-02-09, 1402/11/20
Expected recruitment end date
2025-02-08, 1403/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of antibiotics in washing fluid on inflammatory factors during and after transurethral lithotripsy: a single blind clinical trial
Public title
Antibiotic effect during and after intra-organ stone crushing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in the study and obtaining informed consent aged between 20 and 70 years elective surgery stones smaller than 20 million meters located in the upper lower ureter in CTS without contrast.
Exclusion criteria:
Previous history of urinary system surgery Having simultaneous kidney stones Having anatomical or functional kidney disorders Bilateral ureteral stones Positive urine culture before surgery Use of corticosteroids or antibiotics before surgery Immunodeficiency Taking drugs Causes of immunodeficiency Any active or chronic infection during the last three months Diabetes
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
80 study participants who meet the entry requirements will be randomly split into two equal groups of 40 participants. The randomization method of separate blocks is used to create quadruple blocks for randomization. The first patient's chosen illness will be assigned to the "first group," and the second patient will be assigned to the "second group". Patients are divided into two groups: 1-control group: 0.9% normal saline serum and 2-intervention group: 1000 mg of ceftriaxone antibiotic + 6 liters of 0.9% normal saline.
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study is a single-blind, randomized clinical trial study. The patient or participant will not know how to be placed in the control or intervention groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committees in Medical Medical Research
Street address
Room 604, Sixth Floor, Central Staff Building, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-01-15, 1401/10/25
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1402.020

Health conditions studied

1

Description of health condition studied
Urinary tract infection
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified

Primary outcomes

1

Description
The effect of antibiotics in the lavage fluid on the occurrence of infections during and after intra-organ stone crushing
Timepoint
6-12 hours after surgery
Method of measurement
Laboratory diagnosis (urine culture and inflammatory markers)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: 1000 mg ceftriaxone antibiotic + 6 liters of normal saline 0.9%. they receive
Category
Treatment - Drugs

2

Description
Control group: control group: normal saline serum 0.9
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Mohammad Kazem Aghamir
Street address
Urology Research Center - Sina Hospital - Hassan Abad St. - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.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, Iran.
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?
No
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
Tehran
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 Mohammad Kazem Aghamir
Position
Head of Urology Research Center
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 8561
Email
mkaghamir@tums.ac.ir
Web page address
http://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
En Researchers working in academia, physicians, surgeons and hospitals
Under which criteria data/document could be used
En Any analysis can be done with the consent of the main researcher
From where data/document is obtainable
Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560
What processes are involved for a request to access data/document
En 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.
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