Protocol summary

Summary
Aim of this study is preventive effect of tamsulosin on postoperative ‎urinary retention in benign ‎perianal surgeries.This study is clinical ‎trial and double blinde. Inclusion criteria: 18-50 years; Indications ‎for surgery hemorrhoidectomy; sphincterotomy; incisions; perianal ‎abscess drainage and fistulatomy and fistulectomy. Exclusion criteria: ‎active urinary tract infection; history of neurological disorders; ‎malignancy; urinary incontinence; use of drugs affecting the ‎performance of urination; urology disorder; prostate cancer; bladder ‎cancer; history of urinary stones or urinary obstruction; benign ‎pro static hypertrophy; history of urology surgery; urinary catheter ‎fixed; chronic kidney disease; cardiopulmonary disorders; history of ‎allergy to Tamsulosin; history of treatment and use Tamsulosin. We ‎will divide patients in three group after complete demographic ‎information (age and gender). We will prescribe 0.4 milligram ‎Tamsulosin one dose 6 hours before surgery in 81 patient. We will ‎prescribe 0.4 milligram Tamsulosin one dose 6 hours before ‎surgery and 6 hours after surgery in 81 patient.We will prescribe ‎placebo seems inversion groups.We will examine difficulty in urination ‎or retention urination in 24 hours after surgery by clinical response.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016122720258N22
Registration date: 2017-01-04, 1395/10/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-04, 1395/10/15
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research, Arak University of Medical Sciences
Expected recruitment start date
2016-06-08, 1395/03/19
Expected recruitment end date
2017-06-09, 1396/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preventive effect of tamsulosin on postoperative urinary retention in benign ‎perianal surgeries
Public title
Preventive effect of tamsulosin on postoperative urinary retention in benign ‎perianal surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18-50 years; Indications for surgery hemorrhoidectomy; sphincterotomy; incisions; perianal abscess drainage and fistulatomy and fistulectomy Exclusion criteria: active urinary tract infection; history of neurological disorders; malignancy; urinary incontinence; use of drugs affecting the performance of urination; urology disorder; prostate cancer; bladder cancer; history of urinary stones or urinary obstruction; benign prostatic hypertrophy; history of urology surgery; urinary catheter fixed; chronic kidney disease; cardiopulmonary disorders; history of allergy to Tamsulosin; history of treatment and use Tamsulosin.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 243
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomize by table of random numbers

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Arak University of Medical Sciences
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2016-05-23, 1395/03/03
Ethics committee reference number
IR.ARAK.MU.REC.1395.54

Health conditions studied

1

Description of health condition studied
benign perianal surgeries
ICD-10 code
D30
ICD-10 code description
Benign neoplasm of urinary organs

Primary outcomes

1

Description
urinary retention
Timepoint
24 hour after surgery
Method of measurement
clinical response

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: We prescribe 0.4 milligram Tamsulosin one dose in 6 hours before surgery in 81 patient.
Category
Treatment - Drugs

2

Description
Intervention group: We prescribe 0.4 milligram Tamsulosin one dose in 6 hours before surgery and 6 hours after surgery in 81 patient.
Category
Treatment - Drugs

3

Description
Control group: We prescribe Placebo seems intervention group in 81 patient.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Shahin Fateh
Street address
Valiasr squre, Valiasr hospital
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Rafiee
Street address
Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ali Cyrus
Position
Faculty, Urologist
Other areas of specialty/work
Street address
Shahid Shirodi street, Valiasr square, Valiasr hospital
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
cyrus@yahoo.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Shahin Fateh
Position
Faculty, Surgeon
Other areas of specialty/work
Street address
Shahid Shirodi street, Valiasr squre, Valiasr hospital
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
-
Email
sh.fateh@arakmu.ac.ir
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Yasaman Shariat
Position
resident of surgery
Other areas of specialty/work
Street address
Payambarazam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
shariat@yahoo.com
Web page address
-

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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