The aim of this study is the effect of bladder irrigation with 0.2% chlorhexidine before TURP in patients with Foley catheter regarding postoperative bacteremia decrease
Design
Study groups: Patients with benign prostatic hyperplasia
Study:Randomized , blinded, sham controlled clinical trial with a parallel group The size of sample was 60, clinical trial phase: phase 3
Settings and conduct
Place of study: Alzahra Hospital, Isfahan
These patients were randomly divided into two groups(case and control) according to random table.The study is a double blind clinical trial. The patient and the researcher did not know how to allocate placebo and drug for patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria were male gender, lack of sensitivity to latex, and age range between 50 to 80 years old.
Intervention groups
Intervention group: Chlorhexidine (as medicine) and control group :distilled water(placebo)
Main outcome variables
The amount of bacteremia and procalcitonin after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180209038673N5
Registration date:2021-02-23, 1399/12/05
Registration timing:retrospective
Last update:2021-02-23, 1399/12/05
Update count:0
Registration date
2021-02-23, 1399/12/05
Registrant information
Name
Robab Sheikhpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3623 5958
Email address
r.sheikhpour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2020-02-20, 1398/12/01
Trial completion date
2020-02-20, 1398/12/01
Scientific title
The effect of bladder irrigation with 0.2% chlorhexidine before TURP in patients with foley catheter regarding postoperative bacteremia decrease
Public title
إladder irrigation with 0.2% chlorhexidine before TURP in patients with Foley catheter regarding postoperative bacteremia decrease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male gender
Lack of sensitivity to latex
Age range between 50-80 years old
Exclusion criteria:
Dissatisfaction of patients
Age
From 50 years old to 80 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
We divide each referral into two groups using a randomized table. This table is a collection of numbers. Consider numbers from 1 to 30 for intervention A and numbers 31 to 60 for control B. Then let's move on one of the numbers and move in one of the preset directions and assign the numbers to one of the groups. Thus, patients are completely randomly divided.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients did not aware about prescription drugs (placebo and medication). Also, the person who provided these drugs to patients had no information about the allocation of patients to drug or placebo
Placebo
Used
Assignment
Parallel
Other design features
In this study, 60 patients with Foley catheter were randomly divided into two groups of 30 patients. The bladder of patients in one group is rinsed with distilled water before surgery and the other group with chlorhexidine.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2018-09-25, 1397/07/03
Ethics committee reference number
IR. MUI.MED.REC 1397.073
Health conditions studied
1
Description of health condition studied
Benign prostatic hyperplasia
ICD-10 code
N40.0
ICD-10 code description
Enlarged prostate without lower urinary tract symptoms
Primary outcomes
1
Description
The amount of bacteremia after surgery
Timepoint
6 hours after surgery
Method of measurement
Measurement through blood culture
Secondary outcomes
1
Description
Procalcitonin level
Timepoint
6 hours after surgery
Method of measurement
Serum measurement
Intervention groups
1
Description
Intervention group: The bladder of patients in this group is rinsed with 0.2 percent chlorhexidine before surgery
Category
Treatment - Drugs
2
Description
Control group: The bladder of patients in this group is rinsed with distilled water before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Hamed Jahangiri
Street address
Alzahra hospital, Soffeh Blvd, Shahid Keshvari Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
hamedjahangiri201999@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojgan Mortazavi
Street address
Isfahan University of Medical Science,Hezar Jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
Hamedjahangiri201999@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hamed Jahangiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Isfahan University of Medical Sciences, Hezar jareeb Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
Hamedjahangiri201999@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamed Jahangiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Isfahan University of Medical Science,Hezar Jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
Hamedjahangiri201999@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamed Jahangiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
Hamedjahangiri201999@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Patients were not satisfied with the release of the data file.
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
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available