This study was conducted in Zanjan Hospital and participants through simple randomization divided into intervention and control groups, and double blind study.
Participants/Inclusion and exclusion criteria
Participants : Patients with benign anorectal diseases
inclusion criteria : Both sexes - 20 to 70 years - Indication of hemorrhoidectomy and fistulotomy and sphincterotomy
exclusion criteria : Urinary tract infection - history of neurological disorder - malignancy-urinary incontinence-previous use of tamsulosin
Intervention groups
intervention group percieve tamsulosin and control group percieve placebo before surgery
Main outcome variables
Prevention of urinary retention and urinary complications
General information
Reason for update
Acronym
ZSC
IRCT registration information
IRCT registration number:IRCT20190115042363N1
Registration date:2019-04-21, 1398/02/01
Registration timing:retrospective
Last update:2019-04-21, 1398/02/01
Update count:0
Registration date
2019-04-21, 1398/02/01
Registrant information
Name
Farhad Kheiri tootkaleh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 1851
Email address
farhadkheiri1986@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-06, 1397/04/15
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
2018-07-06, 1397/04/15
Actual recruitment end date
2019-03-19, 1397/12/28
Trial completion date
2019-03-19, 1397/12/28
Scientific title
The efficacy of prophylactic tamsulosin in preventing acute urinary retention after benign anorectal surgeries
Public title
The efficacy of prophylactic tamsulosin in preventing acute urinary retention after benign anorectal surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Both sexes
20 to 70 years
Indication of hemorrhoidectomy and fistulotomy and sphincterotomy
IPSS criteria less than 7
Exclusion criteria:
Urinary tract infection
History of neurological disorder
Malignancy
Urinary incontinence
Use of medications that affect urination
History of drug allergy to tamsulosin
Recent Tamsulosin Uses
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
140
Actual sample size reached:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with a numbered echelon
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to prevent the onset of Bias, placebo was prescribed and blinded. In addition to the fact that the patient is not aware of his group, drug warranties and post-operative evaluation are also performed by a person who is unaware of the patient grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee of Zanjan University of medical science of Medical Sciences
Street address
Zanjan university of medical science, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956111
Approval date
2018-07-03, 1397/04/12
Ethics committee reference number
IR.ZUMS.REC.1397.82
Health conditions studied
1
Description of health condition studied
hemorrhoid
ICD-10 code
K64
ICD-10 code description
Hemorrhoids and perianal venous thrombosis
Primary outcomes
1
Description
Urinary retention
Timepoint
24 hours after surgery
Method of measurement
Clinical response
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who received tamsulosin at a dose of 0.4 mg 12 hours before surgery
Category
Prevention
2
Description
Control group: Patients who received placebo 12 hours before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mousavi hospital
Full name of responsible person
Mohamad naeem bangash
Street address
General surgery department, Mousavi hospital, Gavazang Blvd, Zanjan Town
City
Zanjan
Province
Zanjan
Postal code
45139-56183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
Mousavihospital@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza shoghli
Street address
Zanjan University of medical sciences, Zanjan Town
City
Zanjan
Province
Zanjan
Postal code
45156-13191
Phone
+98 24 3315 6319
Email
research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Mohamad naeem bangash
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
General Surgery department, Mousavi hospital, Zanjan
City
Zanjan
Province
Zanjan
Postal code
45139-56183
Phone
+98 24 3313 0000
Email
gps1376@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohamad naeem bangash
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
General Surgery department, Mousavi hospital, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 243313000
Email
gps1376@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Farhad kheiri tootkaleh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
General Surgery department, Mousavi hospital, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 243313000
Email
farhadkheiri1986@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information will be made available to researchers
When the data will become available and for how long
Six months later and for two years
To whom data/document is available
for researcher
Under which criteria data/document could be used
With the permission of the researcher
From where data/document is obtainable
zanjan university of medical science
What processes are involved for a request to access data/document