Comparison of the Surgical Outcome of Laparoscopic-assisted Extracorporeal Pyeloplasty and Open Dismembered Pyeloplasty in Children with Ureteropelvic Junction Obstruction
Objective: Comparison of the Surgical Outcome of Laparoscopic-assisted Extracorporeal Pyeloplasty and Open Dismembered Pyeloplasty in Children with Ureteropelvic Junction Obstruction.
Design: Interventional, Not-blinded, Non-randomized.
Target sample size: 50 People.
Inclusion Criteria: Children under age 14.
Exclusion Criteria: Dyspepsia; Gastroesophageal reflux disease (GERD) along with ipsilateral UPJO; Any history of ipsilateral UPJO surgery; Anatomical abnormalities such as ectopic or duplicated ureter; Other urinary tract anomalies; Presented contraindications to surgery; Any history of previous abdominal surgery; Abdominal diseases and interventions; Underlying diseases such as coagulopathy.
Intervention group: Surgery of Laparoscopic-assisted Extracorporeal Pyeloplasty.
Control group: Surgery of open Dismembered Pyeloplasty.
Primary outcome measure: During hospitalization period, After surgery, Via hospitalized form; Surgery results, Till 6 months after surgery, Using Clinical examinations.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010920621N1
Registration date:2015-02-25, 1393/12/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-25, 1393/12/06
Registrant information
Name
Parisa Saeedi
Name of organization / entity
Sheykh Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 4499
Email address
saeedipp@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Surgical Outcome of Laparoscopic-assisted Extracorporeal Pyeloplasty and Open Dismembered Pyeloplasty in Children with Ureteropelvic Junction Obstruction
Public title
Treatment of Ureteropelvic Junction Obstruction in infants and children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Children under age 14.
Exclusion Criteria: Dyspepsia; Gastroesophageal reflux disease (GERD) along with ipsilateral UPJO; Any history of ipsilateral UPJO surgery; Anatomical abnormalities such as ectopic or duplicated ureter; Other urinary tract anomalies; Presented contraindications to surgery; Any history of previous abdominal surgery; Abdominal diseases and interventions; Underlying diseases such as coagulopathy
Age
To 14 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not 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
Vice Chancellor for Research, Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi Building, Daneshgah St, Mashhad
City
Mashhad
Postal code
Approval date
2011-07-28, 1390/05/06
Ethics committee reference number
900568
Health conditions studied
1
Description of health condition studied
Uretropelvic junction obstruction in infants
ICD-10 code
Q62.1
ICD-10 code description
Atresia and stenosis of ureter
Primary outcomes
1
Description
During hospitalization period
Timepoint
After surgery
Method of measurement
Hospitalized form
2
Description
Surgery results
Timepoint
Till 6 months after surgery
Method of measurement
Clinical examinations
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Surgery of Laparoscopic-assisted Extracorporeal Pyeloplasty
Category
Treatment - Surgery
2
Description
Control group: Surgery of open Dismembered Pyeloplasty
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheykh Hospital
Full name of responsible person
Parisa Saeedi
Street address
Sheykh Hospital, Gharani 6th St, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Ramezani
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi Building, Daneshgah St, Mashhad
City
Mashhad
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad 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
Sheykh Hospital
Full name of responsible person
Parisa Saeedi
Position
Resident
Other areas of specialty/work
Street address
Sheykh Hospital, Gharani 6th St, Mashhad
City
Mashhad
Postal code
Phone
+98 518400004
Fax
Email
saeedip@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sheyk Hospitalh
Full name of responsible person
Parisa Saeedi
Position
Resident
Other areas of specialty/work
Street address
Sheykh Hospital, Gharani 6th St, Mashhad
City
Mashhad
Postal code
Phone
+98 518400004
Fax
Email
saeedip@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
SheyHospitalkh
Full name of responsible person
Parisa Saeedi
Position
Resident
Other areas of specialty/work
Street address
Sheykh Hospital, Gharani 6th St, Mashhad
City
Mashhad
Postal code
Phone
+98 518400004
Fax
Email
saeedip@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)