Comparison of safety of omitting antibiotic prophylaxis prior to Transurethral Lithotripsy (TUL) in two groups of patients with and without positive urine culture referred to Razi Hospital in Rasht: a pilot study
Determination of the safety of omitting prophylactic antibiotic therapy prior to Transurethral Lithotripsy (TUL) in two groups of patients with and without positive urine culture
Design
Non-randomized controlled trial study, by available gradual and sequential sampling method, with a sample size of 50 patients
Settings and conduct
The study will be performed in the urology ward and operating room of Razi Hospital in Rasht. This pilot study is performed on 50 patients gradually and sequentially. Patients will be divided into two groups based on the result of urine culture: A (positive preoperative urine culture) and B (negative preoperative urine culture). Intraoperative prophylactic antibiotics are prescribed in all patients undergoing Transurethral Lithotripsy (TUL).
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 15 years and under 65 years, patient consent to participate in the study
Exclusion criteria: Patients with symptoms of upper urinary tract infection; Use of preoperative antibiotics; Drug abuse; Patients with single kidney and uncontrolled systemic diseases.
Intervention groups
Intervention group: Omitting antibiotic prior to Transurethral Lithotripsy (TUL) in patients with positive urine culture;
Control group: Patients without positive urine culture in whom antibiotic is not prescribed as standard prior to Transurethral Lithotripsy (TUL)
Main outcome variables
Postoperative fever, urinary tract infection and complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090427001853N17
Registration date:2021-10-24, 1400/08/02
Registration timing:prospective
Last update:2021-10-24, 1400/08/02
Update count:0
Registration date
2021-10-24, 1400/08/02
Registrant information
Name
Siavash Falahatkar
Name of organization / entity
Urology Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 3352 5259
Email address
urc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-31, 1400/08/09
Expected recruitment end date
2022-04-29, 1401/02/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of safety of omitting antibiotic prophylaxis prior to Transurethral Lithotripsy (TUL) in two groups of patients with and without positive urine culture referred to Razi Hospital in Rasht: a pilot study
Public title
Safety of omitting antibiotic prophylaxis prior to Transurethral Lithotripsy (TUL)
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with lower and middle ureteral stones who are candidates for Transurethral Lithotripsy (TUL)
Age between 15 and 65 years
Patient consent to participate in the study
Exclusion criteria:
Upper urinary tract infection based on symptoms of fever, shivering, flank pain and leukocytosis
Use of preoperative antibiotics
Drug abuse
Patients with single kidney
Uncontrolled systemic diseases
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Sardar Jangal street
City
Rasht
Province
Guilan
Postal code
41448-95655
Approval date
2021-09-01, 1400/06/10
Ethics committee reference number
IR.GUMS.REC.1400.250
Health conditions studied
1
Description of health condition studied
Postoperative complication
ICD-10 code
N99.89
ICD-10 code description
Other postprocedural complications and disorders of genitourinary system
Primary outcomes
1
Description
Postoperative fever
Timepoint
After the operation until the time of discharge
Method of measurement
Examination
2
Description
Postoperative urinary tract infection
Timepoint
48 hours after surgery
Method of measurement
Urine culture
3
Description
Postoperative complications
Timepoint
After the operation until the time of discharge
Method of measurement
Examination and laboratory tests
Secondary outcomes
1
Description
Success rate (stone free rate)
Timepoint
1 month after surgery
Method of measurement
Sonography, CT-scan
2
Description
Operation time
Timepoint
From start to recovery
Method of measurement
Stopwatch
3
Description
Hospital stay
Timepoint
On the day of discharge
Method of measurement
Hospitalization days
4
Description
Analgesic use
Timepoint
After surgery, during the period of hospitalization
Method of measurement
Question from the patient, examination
5
Description
Readmission
Timepoint
Up to one month after surgery
Method of measurement
Question from the patient
Intervention groups
1
Description
Intervention group: Omitting prophylactic antibiotic therapy prior to Transurethral Lithotripsy (TUL) in patients with positive urine culture in whom routinely antibiotics are continued until urine culture become negative
Category
Other
2
Description
Control group: Patients without positive urine culture in whom antibiotic is not prescribed as standard prior to Transurethral Lithotripsy (TUL)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Siavash Falahatkar
Street address
Sardar-e-Jangal street
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
urc1384@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Siavash Falahatkar
Street address
Sardar-e-Jangal Street
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
urc@gums.ac.ir
Grant name
10506
Grant code / Reference number
32
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Research Center, Guilan 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
Rasht University of Medical Sciences
Full name of responsible person
Reza Falahatkar
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Sardar-e-Jangal Street
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
rfalahatkar76@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Siavash Falahatkar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Sardar-e-Jangal Street
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
falahatkar_s@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Samaneh Esmaeili
Position
Non-faculty researcher
Latest degree
Master
Other areas of specialty/work
Urology
Street address
Sardar Jangal St.
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
samaneh_815@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