Determining the Effect of Condoms on Prevention of Urinary Retention in Men Following Anorectal Surgery
Design
Clinical Trial
Settings and conduct
Swap to Persian
Patients who undergo various surgeries due to anorectal problems are included in the study. Before surgery, they are examined at an outpatient clinic to diagnose diabetes, high blood pressure and heart disease. The IPSS questionnaire is completed for all patients and patients are divided into three groups based on the score of the questionnaire. (Patients with IPSS Low, Moderate, High). Patients with a history of duct stenosis, urinary stones, neurological disease, urinary incontinence and urinary tract infections, and history of surgical procedures on the urethra are currently excluded from the study. In order to blind, the examiner will be unaware of the grouping of patients.
Swap to Persian
Then, at the appointed time, each patient enters the operating room under standard monitoring. All patients fall under the spinal cord. The fluids received before and during surgery are the same for all patients (5 cc per kg body weight per hour) for each patient.
Participants/Inclusion and exclusion criteria
Patients who undergo various surgeries due to anorectal problems are included in the study.
Patients with a history of duct stenosis, urinary stones, neurological disease, urinary incontinence and urinary tract infections, and history of surgical procedures on the urethra are currently excluded from the study.
Intervention groups
Patients who undergo various surgeries due to ano-rectal problems are randomly allocated in two groups. After the surgery for the patients in the intervention group condom sheets are applied and for the other group no instrument will be used.
Main outcome variables
Urinary retention; total dose of analgesic prescribed (Ketorolac); total dose of narcotic prescribed (Pethidine)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180720040533N1
Registration date:2019-03-27, 1398/01/07
Registration timing:retrospective
Last update:2019-03-27, 1398/01/07
Update count:0
Registration date
2019-03-27, 1398/01/07
Registrant information
Name
Farzad Vaghef Davari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2213 5448
Email address
fvdavari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-12, 1397/07/20
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of condom use on reducing the incidence of urinary retention after anorectal surgeries
Public title
Investigating the effect of condom use on reducing the incidence of urinary retention after anorectal surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who undergo various surgeries due to anorectal problems
Exclusion criteria:
Patients with history of narrowing of the urethra
Patients with a history of urinary stones
Patients with a history of urinary tract infection
Patients with a history of neurological disease
Patients with history of urinary incontinence
Patients with a history of surgery on the urethra
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
172
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects were randomly divided into two groups by the method of Block Randomization
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
National Ethics Committee on Biological Research
Street address
Ministry of Health and Medical Education, shahrake ghods, tehran,iran
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2018-08-04, 1397/05/13
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.315
Health conditions studied
1
Description of health condition studied
Urinary retention in patients undergoing anorectal surgeries
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
prevalence of urinary retention
Timepoint
The prevalence of urinary retention in the first 24 hours after surgery
Method of measurement
Urination or need of fully catheter insersion
Secondary outcomes
1
Description
Total prescribed ketorolac
Timepoint
During hospitalization
Method of measurement
Total dose of drug by mg
2
Description
Total Prescribed Pethidine
Timepoint
During Hospitalization
Method of measurement
By mg
Intervention groups
1
Description
Intervention group: In a group of patients who are in the intervention group, the patient is embedded after anorectal condom shave surgery and is evaluated for the incidence of urinary retention in the first 24 hours after the operation.
Category
Prevention
2
Description
Control group: In this group of patients after anorectal surgery, the patient is examined for urinary retention during the first 24 hours.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Farzad Vaghef Davari
Street address
Sina Hospital-Imam Khomeini St.
City
Tehran
Province
Tehran
Postal code
7732245678
Phone
+98 21 6312 0000
Email
Fvdavari@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohammad Ali Sahraeian
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
2234557890
Phone
+98 21 81630
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
97-01-30-37801
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Bahare Rahmanian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Sina hospital, Imam khomeini street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 63128
Email
Fvdavari@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bahare Rahmania
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Sina hospital, Imam Khomeini street, Tehran
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 2231 8777
Email
Fvdavari@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bahare Rahmanian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Sina hospital, Imam Khomeini st., Tehran
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 2231 8777
Email
Fvdavari@sina.tums.ac.ir
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available