Comparison of expectant and surgical therapy for children suffering from urethropelvic junction obstruction (UPJO)
Design
A non randomized, double blind, sham controlled clinical trial with a parallel group design, consisted of 30 patients, enrolled between February 2020 and February 2021, and followed for one year.
Settings and conduct
The study will be performed on less than 18 year-old children referred to Booali hospital from February 2020 to February 2021.
Sonography to diagnose severity of hydronephrosis, VCUG to diagnose vesico-ureteral reflux (VUR) and renal scan to assess severity of obstruction will be ordered.
Radiologists, Scintigraphy reporters and main co-workers are blinded to patients' grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Less than 18 years of age, history of prenatal or postnatal severe hydronephrosis on sonography ,Normal VCUG, Obstructive renal scan with diminished renal function. Exclusion criteria: Vesicoyreteral Reflux, Bilateral hydronephrosis, Neurogenic bladder, Multicystic dysplastic kidney, unwillingness to participation
Intervention groups
Intervention group: Those patients with severe hydronephrosis who underwent surgical operation for obstruction (pyeloplasty). Control group: Those patients with severe hydronephrosis who didn't undergo surgical operation for obstruction (pyeloplasty).
Main outcome variables
Antroposterior renal pelvic diameter; Grade of hydronephrosis; Improvement of obstruction and function of kidney on renal scan.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141224020419N4
Registration date:2020-06-10, 1399/03/21
Registration timing:registered_while_recruiting
Last update:2020-06-10, 1399/03/21
Update count:0
Registration date
2020-06-10, 1399/03/21
Registrant information
Name
Hamid Mohammadjafari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3331 3866
Email address
hmjafari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between surgical and conservative treatment for severe Ureteropelvic junction obstruction in pediatrics
Public title
UPJO treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All less than 18 yr old patients with grade 3 or 4 hydronephrosis on prenatal all after birth sonography.
Normal VCUG
Severe obstruction and diminished function on functional renal scan.
Exclusion criteria:
Vesicoureteral Reflux
Bilateral Hydronephrosis
Neurogenic Bladder
Multicystic kidney
Not willing to contribute in the study
Age
To 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Improvement status is the main variable that should be blinded. Therefore radiologist and scintigraphic reporters will be blinded. The scintigraphy reporter will be blinded in all times. But the sonographist will be blinded before operation. It is impossible to blind sonographist after surgery because of scar.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Māzandarān University of Medical Sciences
Street address
Vice Chancellor for research, Mazandaran University of Medical Sciences, Moalem square
City
Sari
Province
Mazandaran
Postal code
4818856361
Approval date
2019-12-02, 1398/09/11
Ethics committee reference number
IR.MAZUMS.REC.1398.1174
Health conditions studied
1
Description of health condition studied
Urinary Tract Obstruction
ICD-10 code
N13.1
ICD-10 code description
Hydronephrosis with ureteral stricture, not elsewhere classified
2
Description of health condition studied
congenital Hydronephrosis
ICD-10 code
Q62.0
ICD-10 code description
Congenital hydronephrosis
Primary outcomes
1
Description
Severity of Hydronephrosis in sonography
Timepoint
Before intervention and 3 months and 6 months later
Method of measurement
Sonography
2
Description
Obstruction severity
Timepoint
Before intervention and 12 months later
Method of measurement
Dynamic Renal Scan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Hydronephrotic children (less than 18 years) with severe obstruction that are treated with surgical intervention (pyeloplasty).
Category
Treatment - Surgery
2
Description
Control group: Hydronephrotic children (less than 18 years) with severe obstruction that are not treated with surgical intervention (pyeloplasty).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Booali hospital
Full name of responsible person
Mahgol Sadeghian
Street address
Pasdaran boulevard
City
Sari
Province
Mazandaran
Postal code
4818856361
Phone
+98 11 3334 3018
Fax
+98 11 3334 3015
Email
hamidmjaafari@yahoo.com
Web page address
https://www.mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Vice Chancellor for research, Mazandaran University of Medical Sciences, Moalem square
City
Sari
Province
Mazandaran
Postal code
4818856361
Phone
+98 11 3334 3010
Fax
+98 11 3334 3015
Email
hamidmj46@gmail.com
Web page address
https://www.Mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahgol Sadeghian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Boali hospital, Pasdaran boulevard
City
Sari
Province
Mazandaran
Postal code
4818856361
Phone
+98 11 3334 3010
Fax
+98 11 3331 3866
Email
hmjafari@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandran University of Medical Sciences
Full name of responsible person
Hamid Mohamadjafari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Boali hospital, Pasdaran boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4818856361
Phone
+98 11 3334 3018
Fax
+98 11 3331 3866
Email
hmjafari@mazums.ac.ir
Web page address
https://www.Mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahgol Sadeghian
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Boali hospital, Pasdaran boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4818856361
Phone
+98 11 3334 3018
Fax
+98 11 3334 3015
Email
hamidmjaafari@yahoo.com
Web page address
https://www.mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available