Evaluation of the role of antibiotics in urinary tract infections after ESWL Lithotripsy in patients with the indication of Lithotripsy
Design
98 patients with urinary tract stones who had ESWL indication with negative urine culture before ESWL were included in the study. After randomization, patients were divided into two groups. The first group, patients were treated with cefixime 400 mg daily for half an hour before ESWL and also for one week after ESWL, and the control group was given only single-dose antibiotics after ESWL. Finally, urine culture was taken from all patients 14 days after the procedure.
Settings and conduct
Bushehr University of Medical Sciences, litholapaxy department of urology clinic
Participants/Inclusion and exclusion criteria
Inclusion in the study: Presence of urinary tract stones, indication for ESWL, referral to urology clinic
Exclusion: Non-native patients, dissatisfaction with participation in the study, positive urine culture, relative contraindications
Intervention groups
The first group, which was the case group, patients were treated with cefixime 400 mg daily for half an hour before ESWL and also for one week after ESWL, and the control group was given only single-dose antibiotics after ESWL.
Main outcome variables
Prevention and reduction of infection after ESWL .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200725048205N1
Registration date:2020-08-14, 1399/05/24
Registration timing:registered_while_recruiting
Last update:2020-08-14, 1399/05/24
Update count:0
Registration date
2020-08-14, 1399/05/24
Registrant information
Name
Mahdi Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3372 5581
Email address
dr.m.mohammadi50@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-05, 1399/05/15
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the role of antibiotics in urinary tract infections after ESWL Lithotripsy in patients with the indication of Lithotripsy
Public title
Role of antibiotics in urinary tract infection prevention after lithotripsy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of urinary system stones
Indication of doing ESWL
Refer to the urology clinic
Exclusion criteria:
Non-native patients
Dissatisfaction with participation in the study
Positive urinary culture
Existence of relative contraindications
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: individual
Patients are selected based on randomization with even and odd numbers method.
Patients whose last medical record number is even are in the control group and patients whose last number is odd are in the treatment 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
Ethics committee of Bushehr University of Medical Sciences
Street address
Bushehr Province, Bandar Bushehr, Kuy-e-Bandar, Moallem St
City
Bushehr
Province
Boushehr
Postal code
7514633341
Approval date
2020-06-14, 1399/03/25
Ethics committee reference number
IR.BPUMS.REC.1399.049
Health conditions studied
1
Description of health condition studied
Patients with kidney stones
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
Reduction of urinary tract infection after ESWL
Timepoint
14 days after the end of the test period
Method of measurement
Urine culture
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The control group is given a single dose of Cefsexime 400 mg after ESWL treatment.
Category
Prevention
2
Description
Intervention group: Patients were treated with cefixime 400 mg daily for half an hour before ESWL and also for one week after ESWL.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Persina Gulf Martyrs Hospital, Bushehr
Full name of responsible person
Mehdi Honarkar Ramezani
Street address
Bushehr - Taleghani St. - Persian Gulf Martyrs Medical Center
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3345 5381
Fax
+98 77 3332 3123
Email
MPGH@BPUMS.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza Khamisipour
Street address
Bushehr, Bahmani, Salman Farsi St., Medical Sciences Campus, First Floor
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0178
Email
Research@Bpums.Ac.Ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Mehdi Honarkar Ramezani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Bushehr, Moallem St., In front of the Friday Prayer Place, Bushehr University of Medical Sciences and Health Services
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
MPGH@BPUMS.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mehdi Honarkar Ramezani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Taleghani St., Persian Gulf Martyrs Hospital, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3345 5385
Email
MPGH@BPUMS.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mehdi Honarkar Ramezani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Taleghani St., Persian Gulf Martyrs Hospital, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3345 5375
Email
MPGH@BPUMS.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
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
Title and more details about the data/document
After finishing all the data collected from the people in the study is published.
When the data will become available and for how long
The access period will start one month after the results are published.
To whom data/document is available
Everyone connected to the university and the health system will have access.
Under which criteria data/document could be used
To use and study the results of this study, people who desire visiting the Central Library or the person responsible for the act of Bushehr University of Medical Sciences.
From where data/document is obtainable
Bushehr University of Medical Sciences Central Library
What processes are involved for a request to access data/document