Aim were Comparison of Double J Insertion with Nephrostomy in Pelvic Trauma Management After Percutaneous nephrolithotomy
Design
This evaluation is a phase 4 clinical trial, patients diagnosed with renal stone having PCNL and having trauma to the pelvis were considered as the study group, in this study 60 patients who met the inclusion criteria were chosen. Patients were non randomly divided into two groups by non-blocking method, 28 patients in the double J group and 30 patients in the nephrostomy group. Patients were evaluated 2 weeks after surgery.
Settings and conduct
This clinical trial study was performed at Shahid Hashemi Nejad Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Patients with pelvic trauma and consent to participate in the study were enrolled to study, also patients with a history of kidney stone surgery, bleeding disorders, and taking an anticoagulant drug were excluded from study.
Intervention groups
In the first group, patients were treated with double J stent for treatment and in the second group, nephrostomy was used.
Main outcome variables
Urinary residual volume; fever
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191230045956N1
Registration date:2020-02-08, 1398/11/19
Registration timing:retrospective
Last update:2020-02-08, 1398/11/19
Update count:0
Registration date
2020-02-08, 1398/11/19
Registrant information
Name
mohammad kolbadinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3455 2628
Email address
mohammad_kolbadinezhad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-21, 1396/02/31
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2017-05-21, 1396/02/31
Actual recruitment end date
2018-01-09, 1396/10/19
Trial completion date
2018-01-09, 1396/10/19
Scientific title
Comparison of Double J Insertion with Nephrostomy in Pelvic Trauma Management After Percutaneous nephrolithotomy
Public title
Comparison of Double J with Nephrostomy in Pelvic Trauma Management
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pelvic trauma
Consent to participate in the study
Exclusion criteria:
A history of kidney stone surgery
Bleeding disorders
Taking an anticoagulant drug
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
58
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
Ethics committee of Iran University of Medical
Street address
Next to Milad tower, Hammat highway.
City
Tehran
Province
Tehran
Postal code
1799737737
Approval date
2018-03-03, 1396/12/12
Ethics committee reference number
IR.IUMS.FMD.REC.1396.9311254005
Health conditions studied
1
Description of health condition studied
Calculus of kidney
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
Urinary residual volume
Timepoint
2 weeks after surgery
Method of measurement
Using ultrasound
2
Description
Fever
Timepoint
2 weeks after surgery
Method of measurement
Based on clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group of patients, double J stent were used.
Category
Treatment - Surgery
2
Description
Intervention group: This group of patients were underwent nephrostomy.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Hashemi Nejad Hospital
Full name of responsible person
Mohammad Kalbadi Nejad
Street address
Hashemi Nejad Hospital, Valinezhad St, Tehran
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8116 1811
Email
mohammad_kolbadinezhad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Morteza Naserbakht
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Email
ivco@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mohammad Kalbadi Nejad
Position
Resident of urology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Hashemi Nejad Hospital, Valinezhad St, Tehran
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8116
Email
mohammad_kolbadinezhad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Kalbadi Nejad
Position
Resident of urology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Hashemi Nejad Hospital, Valinezhad St, Tehran
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8116
Email
mohammad_kolbadinezhad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Kalbadi Nejad
Position
Resident of urology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Hashemi Nejad Hospital, Valinezhad St, Tehran
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8116
Email
mohammad_kolbadinezhad@yahoo.com
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