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comparison of combined electro cutter with cold knife with cold knife in the intractable anterior urethral stricture urethrotomy

Protocol summary

Summary
The main aim of this study was to use of combined electro cutter – cold knife urethrotomy In comparison of only cold knife urethrotomy for decreasing recurrence and complication rates in recurrent anterior urethral strictures. The including key criteria in this study were anterior short, single and recurrent strictures (more than two time recurrence) and the excluding key criteria were anterior long, multiple, and first time urethral strictures, and also posterior urethral strictures. In this prospective study 87 male anterior recurrent urethral stricture patient with 18 years old and older were in rolled from the first of May 2010 to the first of Jun 2013. Our patients randomized to two groups by computer generated random numbers. In group A, 45 patients urethrotomised by combined electro cutter – cold knife, and in group B , urethrotomy was performed only by cold knife. Patients followed for 6 months (in 15, 30, and 180 day durations). Follow-up procedures were physical examinations, uroflowmetery,retrograde urethrography , and record of any complication symptoms in every duration. Urethral stricture improving and urethral stricture recurent rate as primary out comes assisted by uroflowmetery and retrograde urethrography in 15,30 and 180 day durations after intervention .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201501071981N5
Registration date: 2015-01-15, 1393/10/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-15, 1393/10/25
Registrant information
Name
Ali Asghar Ketabchi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 4348
Email address
a_ketabchi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Physiology Research Center , Kerman University of Medical Sciences
Expected recruitment start date
2010-05-01, 1389/02/11
Expected recruitment end date
2013-06-01, 1392/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of combined electro cutter with cold knife with cold knife in the intractable anterior urethral stricture urethrotomy
Public title
Evaluation of combined electro cutter urethrotomy in the intractable anterior urethral stricture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :anterior urethral stricture;short and single urethral stricture;recurent urethral stricture exclusion criteria :posterior urethral stricture;long and multiple anterior urethral stricture;first time urethral stricture
Age
From 18 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 87
Randomization (investigator's opinion)
Randomized
Randomization description
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
Kerman University of Medical Science Research Center
Street address
Kerman University of Medical Science
City
Kerman
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
k/372/93

Health conditions studied

1

Description of health condition studied
urethral stricture
ICD-10 code
N99.1
ICD-10 code description
Postprocedural urethral stricture

Primary outcomes

1

Description
urethral stricture improve
Timepoint
15day ,30 day , and 3 months after intervention
Method of measurement
uroflowmetry

2

Description
urethral stricture recurent rate
Timepoint
15day ,30 day, and 3 months after intervention
Method of measurement
uroflowmetry and retrograde urethrography

Secondary outcomes

1

Description
dysuria
Timepoint
15day ,30 day , and 3 months after intervention
Method of measurement
questionnaire

2

Description
quality of life
Timepoint
15day ,30 day , and 3 months after intervention
Method of measurement
questionnaire

Intervention groups

1

Description
in Intervention group :urethrotomy performed by an optical combined electrocutter-cold knife urethrotom internaly in one stage
Category
Treatment - Surgery

2

Description
in control group:urethrotomy performed by a cold knife urethrotom internaly in one stage
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahonar Hospital (urology department)
Full name of responsible person
Dr.Ali Asghar Ketabchi
Street address
Bahonar Hospital urology department
City
kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Physiology Research Center , Kerman University of Medical Sciences
Full name of responsible person
Dr. Hamid Najafi
Street address
Research Building, Somaie Square
City
kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physiology Research Center , Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Dr. Ali Asghar Ketabchi
Position
Urology Associate Professor
Other areas of specialty/work
Street address
Urology Department, Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 3211 4348
Fax
Email
a_ketabchi@kmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Ali Asghar Ketabchi
Position
Urology Associate Proferssor
Other areas of specialty/work
Street address
Urology Department, Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 3211 4348
Fax
Email
a_ketabchi@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Ali Asghar Ketabchi
Position
Urology Associate Professor
Other areas of specialty/work
Street address
Urology Department, Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 3211 4348
Fax
Email
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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