Comparison of treatment outcomes between endoscopic injection of new bulking agent of Vantris® and open surgery of Gil-vernet in 1-10 year-aged children with primary vesicoureteral reflux(VUR)
The objective is to compare the results of treatment of primary VURs using single injection of Vantris with Gil-Vernet open surgery in 1-10 years old children. 100 renal units involved with VUR in a randomized clinical manner were included in this study. VUR is diagnosed and graded using VCUG. VURs with grade II to IV are the target patients. Other grades of VUR, anatomic abnormalities, neurogenic bladder and previous surgeries on lower urinary tract are excluded from the study. Follow-up VCUG is to be done after 3 months. the surgical efficacy is defined as a decrease or resolution of VUR seen at VCUG.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015022321211N1
Registration date:2015-04-24, 1394/02/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-24, 1394/02/04
Registrant information
Name
M. Reza Roshandel
Name of organization / entity
Tabriz Univercity Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7328
Email address
roshandelmr@yahoo.com
Recruitment status
Recruitment complete
Funding source
Health curriculum (of Health Ministry)
Expected recruitment start date
2013-08-22, 1392/05/31
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of treatment outcomes between endoscopic injection of new bulking agent of Vantris® and open surgery of Gil-vernet in 1-10 year-aged children with primary vesicoureteral reflux(VUR)
Public title
Comparison of treatment outcomes between endoscopic injection of new agent of Vantris® and open surgery of Gil-vernet in 1-10 year-aged children with primary vesicoureteral reflux
Purpose
Treatment
Inclusion/Exclusion criteria
Iinclusion criteriae: 1)1-10 years of old ; 2) II to IV grade VURs, as defined below: a) Symptomatic UTIs(such as fever,dysuria,poor feeding, FTT); New renal scarring despite of antibiotic prophylaxis; bilateral VUR; Intolerance to prophylactic antibiotics; parent tendency to surgical repair. Exclusion criteriae: 1)Grades I and V ; 2) previously open or endoscopic surgeries on bladder or ureters ; 3) Anantomic malformations of urinary tract such as obstructive disorders or complete duplication of pyelocaliceal system ; 4)suspicion to or confirmed voiding disorder : a. presence of related clinical findings including abnormal neurologic exam or elimination disorder(instinal and urinary, with together); b.VCUG or ultrasonographic abnormalities such as bladder wall abnormalities or diverticuli ortrabeculation or decreased vesical capacity ; 5)Neurogenic bladder
Age
From 1 year old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
the Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences (TUOMS
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, Golgasht street,University Street, PO Box: 516566593
City
Tabriz
Postal code
Approval date
2015-02-08, 1393/11/19
Ethics committee reference number
5/4/10953
Health conditions studied
1
Description of health condition studied
Vesicouretral reflux
ICD-10 code
Q62.7
ICD-10 code description
Congenital vesico-uretero-renal reflux
Primary outcomes
1
Description
Grade of VUR
Timepoint
3 months
Method of measurement
Grading system for VUR on VCUG, )International Reflux Study Committee )
Secondary outcomes
1
Description
Unimproved VUR
Timepoint
3 months
Method of measurement
Grading system for VUR on VCUG, )International Reflux Study Committee )
Intervention groups
1
Description
Control: Gil-vernet open surgery ;The ureteral orifices are advanced across the trigone by means of a single submucosal mattress suture in order to increase the intramural length and muscular support of each distal ureter.
Category
Treatment - Surgery
2
Description
Intervention: ٍEndoscopic Vantris; In patients with grade I-III VUR, the usual technique of subureteric transurethral injection, with the needle is to be introduced submucosally under the ureteral orifice at the 6 o’clock position'using cystocopes 6 Fr and needles 3.7 Fr. in those with a widely open orifice, the injection is to be performed inside the orifice,as needed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza and Children Hospital
Full name of responsible person
Dr Fahimeh Kazmi Rashed
Street address
Sheshgelan street, Tabriz Children Hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Of Research Of Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Rashidi, Vice Chancellor Of Research
Street address
3rd floor ,No 10, Faculty Of Medicine,Golgasht street, Vice Chancellor Of Research
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Research Of Tabriz 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
Tabriz Univercity Of Medical Scinces
Full name of responsible person
Mohammad Reza Roshandel
Position
Urology Resident
Other areas of specialty/work
Street address
Urology department, Imam Reza Hospital, Golgasht street, Tabriz university of medical sciences
City
Tabriz
Postal code
Phone
+98 41 3335 7328
Fax
Email
roshandelmr@yahoo.com
Web page address
www.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr Fahimeh Kazemi Rashed
Position
Children Urology Flowship
Other areas of specialty/work
Street address
Urology department, Imam Reza Hospital, Golgasht street, Tabriz university of medical sciences
City
Tabriz
Postal code
Phone
+98 41 3335 7328
Fax
Email
kazemirashedf@yahoo.com
Web page address
www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Univercity Of Medical Sciences
Full name of responsible person
Tannaz Aghaei Badr
Position
intern
Other areas of specialty/work
Street address
Urology department, Imam Reza Hospital, Golgasht street, Tabriz university of medical sciences
City
Tabriz
Postal code
Phone
+98 41 3335 7328
Fax
Email
aghayit_md@yahoo.com
Web page address
www.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)