Comparison of results and complications of percutaneous nephrostomy and hemodialysis for hemostasis in patients suffering from obstructive uropathy
Design
30 patients with supra vesical obstructive uropathy referred to imam Khomeini s ER, after being informed about the study conditions and signing the consent were included in intervention 2-3 phase study.
patients were divided to 2 groups randomly by using 4 block randomization .
Group A: Patients will under go unilateral or bilateral per-cutaneous nephrostomy , urine output in the first hour and then every 6 hours post-operative will be checked to reach the optimum level suitable for elective surgery.
Group B: A hemodialysis catheter will be inserted for these patients and the patients undergo internal medicine hemodialysis protocol and the BUN, Cr, Na, K level will be checked every 6 hours. The hemodialysis may be repeated before surgery in order to balance the electrolytes for surgery the complications of both groups such as failure of hemodialysis, failure of percutaneous nephrostomy and other unpredictable complication will be recorded.
T1: The time between admission and reaching optimal electrolyte level surgery. Then the patients will undergo the major surgery such as ureteroscopy , jj insertion or resolving the obstruction. The electrolyte changes will be recorded until discharge.
T2: The time between major surgery and discharge.
T3: Duration of admission.
T1 , T2 , T3 , pain level and the satisfaction level of the patients and complications of surgery will be compared in both groups.
Settings and conduct
This study will be conducted in the Imam Khomeini hospital. Because of the therapeutic procedures, blinding was not possible for the patients and physician. Outcome evaluators were not aware of the randomization protocols.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with obstructive uropathy who could not be operated urgently because of electrolyte disturbance.
Exclusion criteria: Coagulopathy, active cutaneous infection of the flank and severe cardiovascular disorder
Intervention groups
Group A: Patients will under go unilateral or bilateral percutaneous nephrostomy.
Group B: A hemodialysis catheter will be inserted for these patients and the patients undergo internal medicine hemodialysis protocol.
Main outcome variables
The time between admission and reaching optimal electrolyte level for surgery؛
The time between major surgery and discharge؛
Failure of hemodialysis؛
Failure of percutaneous nephrostomy؛
Duration of admission
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150509022168N5
Registration date:2018-01-15, 1396/10/25
Registration timing:registered_while_recruiting
Last update:2018-01-15, 1396/10/25
Update count:0
Registration date
2018-01-15, 1396/10/25
Registrant information
Name
Dinyar Khazaeli
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3221 0695
Email address
khazaeli-d@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-11, 1396/09/20
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of results and complications of percutaneous nephrostomy and hemodialysis for hemostasis in patients suffering from obstructive uropathy
Public title
Comparison of percutaneous nephrostomy and hemodialysis for hemostasis in patients suffering from obstructive uropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with obstructive uropathy who could not be operated urgently because of electrolyte disturbance
Exclusion criteria:
Coagulopathy
Active cutaneous infection of the flank
Severe cardiovascular disorder
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided to 2 groups randomly by using permutation 4 block randomization. Randomization is done with random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the types of therapies, blinding is not possible for the patient and physician.The outcome evaluator should not be aware of how people are treated in treatment groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan blv, Ahvaz Jundishapur University of Medical Sciences
City
Ahwaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2017-12-05, 1396/09/14
Ethics committee reference number
IR.AJUMS.REC.1396.704
Health conditions studied
1
Description of health condition studied
Obstructive uropathy
ICD-10 code
N13
ICD-10 code description
Obstructive and reflux uropathy
Primary outcomes
1
Description
The time between admission and reaching optimal electrolyte level surgery
Timepoint
From the referral of the patient until the proper condition of water and electrolyte for action
Method of measurement
Hour
2
Description
The time between major surgery and discharge
Timepoint
From the patient's main surgery until discharge
Method of measurement
Hour
3
Description
Failure of hemodialysis
Timepoint
After surgery
Method of measurement
Based on patient records
4
Description
Failure of percutaneous nephrostomy
Timepoint
After surgery
Method of measurement
Based on patient records
5
Description
Duration of admission
Timepoint
From patient admission to discharge
Method of measurement
Hour
Secondary outcomes
1
Description
Blood urea nitrogen
Timepoint
At the first hour and then every 6hours post operative will be checked to reach the optimum level suitable for elective surgery.
Method of measurement
Laboratory test
2
Description
Blood creatinine
Timepoint
At the first hour and then every 6hours post operative will be checked to reach the optimum level suitable for elective surgery.
Method of measurement
Laboratory test
3
Description
Blood sodium
Timepoint
At the first hour and then every 6hours post operative will be checked to reach the optimum level suitable for elective surgery.
Method of measurement
Laboratory test
4
Description
Blood potassium
Timepoint
At the first hour and then every 6hours post operative will be checked to reach the optimum level suitable for elective surgery.
Method of measurement
Laboratory test
Intervention groups
1
Description
Intervention group: Patients will under go unilateral or bilateral percutaneous nephrostomy.
Category
Treatment - Surgery
2
Description
Intervention group: A hemodialysis catheter will be inserted for these Patients and the Patients undergo internal medicine hemodialysis protocol
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dinyar Khazaeli
Street address
Azadegan boulevard
City
Ahwaz
Province
Khouzestan
Postal code
1234587659
Phone
+98 61 3221 6104
Email
dinyar.khazaeli@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz, Golestan Blvd, Ahvaz Jundishapur University of Medical Sciences
City
Ahwaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8594
Email
info@ajums.ac.ir
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 and Technology of Ahvaz Jundishapur University of Medical
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
Ahvaz University of Medical Sciences
Full name of responsible person
Dinyar Khazaeli
Position
Fellowship of robotic urologic surgeries and onco-urology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Azadegan Blvd, Imam khomeni hospital
City
Ahvaz
Province
Khouzestan
Postal code
1234587659
Phone
+98 61 3221 6104
Email
khazaeli-d@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dinyar Khazaeli
Position
Fellowship of robotic urologic surgeries and onco-urology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Azadegan Blvd, Imam khomeini hospital
City
Ahvaz
Province
Khouzestan
Postal code
1234587659
Phone
+98 61 3221 6104
Email
khazaeli-d@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dinyar Khazaeli
Position
Fellowship of robotic urologic surgeries and onco-urology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Azadegan Blvd, Imam Khomeini Hospital
City
Ahwaz
Province
Khouzestan
Postal code
1234587659
Phone
+98 61 3221 6104
Fax
Email
dinyar.khazaeli@gmail.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