The effectiveness of cefazolin prophylaxis on infection after TUL surgery
Design
A single-blind clinical trial with interventional and control groups using placebo based on randomized whit random-numbered table.
Settings and conduct
One hour before surgery, the first group (intervention group) is given an intravenous dose of cefazolin 1gr (from the pharmaceutical company Aria). To the second group (control group) 1 hour before surgery, placebo, which is normal saline serum, is given. The placebo will be designed similar to cefazolin.
48-72 hours before giving cefazolin or placebo to each group, we examine body temperature (T), urine culture (U / C), and urine analysis (U / A) of patients. Patients who lack bacteriuria and fever and have negative urine culture are studied and otherwise excluded from the study. 24 hours after the TUL surgery, U / A, U / C and body temperature (T) will be re-established and re-determined. We will evaluate the results by statistical analysis before and after the operation, and thus we will examine the efficacy of cefazolin prophylaxis.
Participants/Inclusion and exclusion criteria
All patients with ureter stone who need transureteral lithotripsy (TUL) and are satisfied. patients don't have ureteral stent, don't have urethral catheter, don't have bacteriuria, have negative urine culture before TUL, have no immune deficiency.
Intervention groups
1. A group that receives prophylaxis antibiotics (cephazolin).
2. A group that receives placebo.
Main outcome variables
urine culture
urine analysis
body temperature
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160514027893N2
Registration date:2018-10-08, 1397/07/16
Registration timing:prospective
Last update:2018-10-08, 1397/07/16
Update count:0
Registration date
2018-10-08, 1397/07/16
Registrant information
Name
Ramin Haghighi
Name of organization / entity
North Khorasan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 3272 4475
Email address
haghighi.ramin@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cefazolin prophylaxis on infection after TUL surgery
Public title
effect of cefazolin prophylaxis in TUL surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with ureter stone who need transureteral lithotripsy (TUL) and are satisfied.
Exclusion criteria:
Patients who don't have ureteral stent or urethral catheter.
Patients who don't have bacteriuria.
Negative urine culture before TUL.
No immune deficiency.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups of intervention and control by random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
After selecting and randomizing, patients will be divided into a and b groups. The surgeon, statistical analyzer and those who will evaluate outcome, will not be informed how to patients allocated in groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of North Khorasan University of Medical Sciences
Street address
medical School.Shahriar Ave.Bojnord.North Khorasan.Iran
City
bojnord
Province
North Khorasan
Postal code
9453155174
Approval date
2018-05-15, 1397/02/25
Ethics committee reference number
IR.NKUMS.REC.1397.016
Health conditions studied
1
Description of health condition studied
ureteral stone
ICD-10 code
N20.1
ICD-10 code description
Calculus of ureter
Primary outcomes
1
Description
Evaluation of bacteriuria based on urine culture and urine analysis
Timepoint
24 hours after TUL surgery
Method of measurement
Evaluation of urine analysis and urine culture
Secondary outcomes
1
Description
Evaluation of patient fever with thermometer
Timepoint
24 hours after TUL surgery
Method of measurement
With thermometer
2
Description
Evaluation of urinary culture
Timepoint
24 hours after TUL surgery
Method of measurement
Urine culture test
3
Description
Urinalysis test
Timepoint
24 hours after TUL surgery
Method of measurement
Urinalysis test
Intervention groups
1
Description
Intervention group: A group that receives prophylaxis antibiotics. Cefazolin is given at a dose of 1gr (intravenous) from Aria Pharmaceutical Company.
Category
Prevention
2
Description
Control group: A group that receives placebo (normal saline). Normal saline serum from Samen Pharmaceutical Company
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hasan Hospital
Full name of responsible person
Ramin Haghighi
Street address
Esfarayen Road, 4 km of Arkan, Imam Hasan Hospital
City
Bojnourd
Province
North Khorasan
Postal code
9453155174
Phone
+98 58 3222 1910
Email
info@nkums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Amirhosein Khoshi
Street address
Esfarayen Road, 4 km of Arkan, Imam Hasan Hospital
City
Bojnourd
Province
North Khorasan
Postal code
9453155174
Phone
+98 58 3229 7096
Email
ah.khoshi@nkums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Ahmad Kameli
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Shahriar Ave, School of Nursing and Midwifery
City
Bojnourd
Province
North Khorasan
Postal code
9453155174
Phone
+98 58 3222 1910
Email
ahmad_kamely@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Ramin Haghighi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Esfarayen Road, 4 km of Arkan, Imam Hasan Hospital
City
Bojnourd
Province
North Khorasan
Postal code
9453155174
Phone
+98 58 3222 1910
Email
haghighi.ramin@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mohammad Taheri
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Esfarayen Road, 4 km of Arkan, Imam Hasan Hospital
City
Bojnourd
Province
North Khorasan
Postal code
9453155174
Phone
+98 58 3222 1910
Email
sky7.mt@gmail.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available