A comparative study of The new technique Meatal mobilization with
glenoplasty and conventional MAGPI in distal hypospadias repair
Hypospadiasis- dislocation of meatus in ventral aspect of Penis- is
one of the most common anomalies in pediatric urologic disease.
The most popular surgical therapy in Distal Hypospadiasis is MAGPI
method.
In classic MAGPI, especially in cases that meatus has not enough
mobilization, curvature deformity due to glans retraction, is the
worse consequence.
In this study a new method will be introduced which the urethra is
released and obtaining the enough length, it will be sutured to the
tip of glans.
Its results will be compared with classic MAGPI method.
This is a randomized clinical trial study on 88 patients with distal
hypospadias who have no chordee and have not done previous repair
surgery at all. The study will be performed on 2 randomized groups,
first on 66 patients whom will be operated by new method and the
second group includes 22 patients for classic MAGPI method. The study
will carry out as single blind study, meaning that the referees have
no knowledge about the groups. Patients will be visited in one week,
three months and six months after surgery by two urologist referees,
to evaluate the cosmetic outcome, meatus retraction and meatal
stenosis. Data will be processed by 16.0 version of SPSS software and
in case of better results, this innovated method shall be introduced
as the superior method in treatment of distal hypospadias.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111238173N1
Registration date:2012-06-28, 1391/04/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-28, 1391/04/08
Registrant information
Name
Babak Kazemzadeh Azad
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1839 0521
Email address
dr.b.kazemzadeh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of The new technique Meatal mobilization with glenoplasty and conventional MAGPI in distal hypospadias repair
Public title
The New Modified MAGPI In Hypospadiasis Repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with distal hypospadiasis including glandular, cronal and subcronal ,refered to the office or clinic and unthergone MAGPI surgery
Exclusion criteria: Patients with the history of previous operation and patients with chordee
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
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
Vice chancellor for research, Kermanshah university of medical sciences
Street address
Beheshti Blv. second building, research and technology department
City
Kermanshah
Postal code
Approval date
2012-05-06, 1391/02/17
Ethics committee reference number
1261
Health conditions studied
1
Description of health condition studied
Hypospadiasis
ICD-10 code
Q54.0
ICD-10 code description
Hypospadias, balanic
Primary outcomes
1
Description
cosmetic
Timepoint
1week,3 months and 6 monthe after surgery
Method of measurement
cone shape glans- central meatus- slit like meatus
2
Description
duration
Timepoint
from the first incision to the last dressing
Method of measurement
minute
Secondary outcomes
1
Description
complications
Timepoint
1 week, 3 months and 6 months after repair
Method of measurement
Meatal stenosis( inability to pass a 6 or 8 french catheter)- Meatal Retraction
2
Description
Urinary Pattern
Timepoint
1 week, 3 months and 6 months after repair
Method of measurement
appropriate diameter, force ang angel of micturation due to referees ideas
Intervention groups
1
Description
In the Control group the operation will be done as traditional MAGPI method (whiout releasing the urethra)
Category
Treatment - Surgery
2
Description
In the Intervention group, a wedge like incision is done ,distal to the meatus up to the tip of Glans; then according to the size of Glans , Urethra will be released and sutured to the tip of Glans in dorsal, lateral and medial side. the rest of the operation is done by routin Glenoplasty
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital, Kermanshah
Full name of responsible person
Dr. Mahmoodreza Moradi
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Second building of medical university, Beheshti Blv. , Vice chancellor for research and technology
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
University of medical sciences
Full name of responsible person
Dr. Mahmoodreza Moradi
Position
associated professor and Pediatric Urologist
Other areas of specialty/work
Street address
Medical University, Shiroodi Blv., University St., Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6324
Fax
Email
bab1412000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of medical sciences
Full name of responsible person
Dr. Mahmoodreza Moradi
Position
Pediatric Urologist
Other areas of specialty/work
Street address
Emam Reza Hostital, Parastar Blv., Kermanshah
City
kermanshah
Postal code
Phone
+98 83 1427 6324
Fax
Email
bab1412000@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Babak Kazemzadeh azad
Position
resident of Urology
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Blv., Kermanshah
City
Kermanshah
Postal code
Phone
00
Fax
Email
bab1412000@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)