This study is a randomized clinical trial with 80 patients between 1 to 12 years old with ant or mid hypospadiasis without chordea. They will be operated by two methods of interrupted and continues suturing. All of the surgery will be done by one expert surgeon and assistant. These patients will be visited one week and three months after stent removal for comparison of success and side effects of these two methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107257110N1
Registration date:2012-05-04, 1391/02/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-04, 1391/02/15
Registrant information
Name
Amir Afyooni
Name of organization / entity
Kermanshah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1824 0307
Email address
dr.afyooni@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah university of medical sciences
Expected recruitment start date
2011-07-02, 1390/04/11
Expected recruitment end date
2011-12-02, 1390/09/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study between interrupted suture and continuous suture in Snodgrass surgery techniques for hypospadias repair
Public title
Comparing two methods of suturing in repairing hypospadiasis using Snodgrass technique
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: affliction of anterior or middle hypospadiasis; age between 1 to 12 years. Exclusion criteria: history of circumcision; history of any treatment in past; history of chordea of penis.
Age
From 1 year old to 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah university of medical sciences
Street address
kermanshah University of Medical Sciences, Shahid Beheshti blvd.
City
Kermanshah
Postal code
Approval date
2011-06-28, 1390/04/07
Ethics committee reference number
7/420/102/پ
Health conditions studied
1
Description of health condition studied
hypospadias
ICD-10 code
Q54
ICD-10 code description
Hypospadias
Primary outcomes
1
Description
Fistule
Timepoint
One week and three months after intervention
Method of measurement
Visiual
2
Description
Urethral stricture
Timepoint
One week and three months after intervention
Method of measurement
Unpossibility of insertion of 6 or 8 fr stent through newly made urethra
3
Description
Break down of the repair
Timepoint
One week and three months after intervention
Method of measurement
Visual
Secondary outcomes
1
Description
Time of the operation
Timepoint
From the first incision until dressing the wound
Method of measurement
Minute
Intervention groups
1
Description
tubularization in Snodgrass technique by continues sutures
Category
Treatment - Surgery
2
Description
tubularization in Snodgrass technique by separate sutures
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Amir Afyooni
Street address
Emam reza hospital, Zakariya Razi blvd
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah university of medical sciences
Full name of responsible person
Dr Mahmudreza Moradi
Street address
Vice chancellery for research & technology, Kermanshah university of medical sciences, building 2, Shahid Beheshti blvd.
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?