Effect of enema with iodine on infection rate after transrectal prostate biopsy in patients suspected of prostate cancer in Imam Reza Hospital during years 2016-2019
Study the effect of enema with iodine on infection rate after transrectal prostate biopsy in patients suspected of prostate cancer
Design
This study is a one-blinded clinical trial. The research population will be included all patients referred to the urology ward of Imam Reza Hospital in Kermanshah. 230 eligible patients will be selected conveniently and randomly assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted at Imam Reza hospital of Kermanshah, is a one-blinded one that the data analyst is blind to the allocation of study groups. At the beginning of the study, the severity of pain, body temperature, and fever and chills were recorded in a checklist for each of the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients whose serum PSA levels have increased; age between 50-68 years
Exclusion criteria: Patients with normal rectal tenderness
Intervention groups
The intervention group will receive 600 cc betadine with 100 cc lidocaine by injected into the rectum and after 5 minutes the prostate biopsy will be performed with the normal saline enema. The control group will not receive any intervention
Main outcome variables
Pain severity, body temperature
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N148
Registration date:2020-04-23, 1399/02/04
Registration timing:prospective
Last update:2020-04-23, 1399/02/04
Update count:0
Registration date
2020-04-23, 1399/02/04
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-28, 1399/02/09
Expected recruitment end date
2020-07-30, 1399/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of enema with iodine on infection rate after transrectal prostate biopsy in patients suspected of prostate cancer in Imam Reza Hospital during years 2016-2019
Public title
Study the effect of enema with iodine on infection rate after transrectal prostate biopsy in patients suspected of prostate cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients whose serum PSA levels have increased
Age between 50-68years
Exclusion criteria:
Patients with normal rectal tenderness
Age
From 50 years old to 68 years old
Gender
Male
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
230
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table, patients are divided into three groups of 115. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the first intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the second intervention group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, data analysts is kept blind to the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-11-04, 1398/08/13
Ethics committee reference number
ir.kums.rec.1398.785
Health conditions studied
1
Description of health condition studied
acute prostatitis
ICD-10 code
N41.0
ICD-10 code description
Acute prostatitis
Primary outcomes
1
Description
Pain severity
Timepoint
The beginning of the study and one day after the end of the intervention
Method of measurement
Using visual scale of pain (VAS)
2
Description
Body temperature
Timepoint
The beginning of the study and one day after the end of the intervention
Method of measurement
Using a thermometer
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive 600 cc betadine with 100 cc lidocaine by injected into the rectum and after 5 minutes the prostate biopsy will be performed with the normal saline enema.
Category
Treatment - Drugs
2
Description
The control group will not receive any intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Ramin Ardeshiri
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Ramin.ardeshiri100@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Ramin Ardeshiri
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
Urology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Ramin.ardeshiri100@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farajolah Parhoudeh
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
fparhoudeh@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ramin Ardeshiri
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
Urology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Ramin.ardeshiri100@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Yes - There is 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
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
Send E-mail to the responsible for the update to get the documentation
What processes are involved for a request to access data/document
Documentation will be emailed within a 15-day timeframe