Introduction and objectives. The irrigation fluid that routinely used during PCNL has systemic absorption and may lead to hyponatremia or hemolysis. Aim of this study is comparing efficacy and adverse effect of sterile water and normal saline as an irrigation fluid in percutaneous nephrolithotomy (PCNL).
Material and methods: ninety four adult patients older than 18 years old with renal or upper ureteral stones that candidate for PCNL after taking informed consent form and approval of ethic committee of Yasuj University of Medical Sciences randomly allocated in two groups. Patient with ASA score 3 and 4 and history of hemolysis excluded from study. From all patient serum base laboratory and serum electrolyte was taken. Then under spinal anesthesia PCNL was done with fluoroscope guidance in prone position by standard method with use of normal saline in first group. In second group PCNL with fluoroscope guidance in standard method with use of sterile water was done too. Preoperative, intraoperative and postoperative variables such as serum sodium, potassium and haptoglobin, cost of irrigation fluid, duration of surgery, pulmonary and cardiovascular complications will be compare between two groups. Data will be collected by observation and questionnaire and will compare with statistical tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212291323N5
Registration date:2013-02-11, 1391/11/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-11, 1391/11/23
Registrant information
Name
Sadrollah Mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3334 6070
Email address
dr.mehrabi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasuj University of Medical Sciences
Expected recruitment start date
2011-06-01, 1390/03/11
Expected recruitment end date
2013-03-01, 1391/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of efficacy and adverse effects of sterile water and normal saline for irrigation fluid in percutneous nephrolithotripsy(PCNL)
Public title
sterile water and normal saline in PCNL
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion and exclusion criteria are includes (Inclusion criteria:Age>18 years old ,patients with renal or upper ureteral stone larger than 20 millimeter candidate for percutaneous nephrolithotripsy ,
Exclusion criteria: patients with urinary stone younger than 18 years old ,patients with azotemia.uncontrolled coagulopathy,active infection,history of hemolysis,any contraindication for general or spinal anesthesia,COPD,ASA score 3 and 4 )
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Yasuj University of Medical Sciences
Street address
Motahari street,yasuj university of medical sciences
City
Yasuj
Postal code
Approval date
2011-03-01, 1389/12/10
Ethics committee reference number
23/8/2876/پ
Health conditions studied
1
Description of health condition studied
Calculus of kidney with calculus of ureter
ICD-10 code
N20.2
ICD-10 code description
Calculus of kidney with calculus of ureter
Primary outcomes
1
Description
cheke of serum electrolytes and hemolysis in percutaneous nephrolithotripsy
Timepoint
Before operation and 6 hour after operation
Method of measurement
checking Na,K,and serum haptoglubin before and 6 hour operation
Secondary outcomes
1
Description
development of any cardiovascular or pulmonary complications
Timepoint
during operation to one week later
Method of measurement
report of patients and observation with examination lung and heart of of patients pulse oximetery during operation,and check of lower limb pulses
Intervention groups
1
Description
Case group :use of sterile water as an irrigation fluid during PCNL operation
Category
Treatment - Surgery
2
Description
control group :use of normal saline as an irrigation fluid during PCNL operation
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Behehti Hospital
Full name of responsible person
Dr Sadrollah Mehrabi
Street address
Shaheed Beheshti hospital, Montazeri street,Yasuj
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of information and Research , Yasuj University of Medical Science
Full name of responsible person
Dr Mehdi Akbartabar
Street address
Motahari street,Yasuj University of Medical Sciences,
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of information and Research , Yasuj University of Medical Science
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
Social Health Determinant of research center,Yasuj university of medical science
Full name of responsible person
Dr Sadrollah Mehrabi
Position
Professor,Chairman of surgery,Fellowship of Endourology, Urology Department, Yasuj University of Med
Other areas of specialty/work
Street address
Montazeri street,Shaheed Beheshti Hospital,
City
Yasuj
Postal code
7591741417
Phone
+98 74 1222 1813
Fax
+98 98741
Email
sadrollahm@yahoo.com and dr mehrabiyums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Social determinant of health research center,, Yasuj University of Medical Science
Full name of responsible person
Dr Sadrollah Mehrabi
Position
chairman of surgery,professor
Other areas of specialty/work
Street address
Block 22,no1,bahonar street,Dr Mehrabi
City
Yasuj
Postal code
Phone
+98 74 1222 1813
Fax
Email
sadrollahm@yahoo.com and dr.mehrabi@yums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
, Fellowship of Endourology, Urology Department, Yasuj University of Medical Science
Full name of responsible person
Dr Sadrollah Mehrabi
Position
chairman of surgery,professor
Other areas of specialty/work
Street address
City
Yasuj
Postal code
Phone
00
Fax
+98 74 1222 6517
Email
sadrollahm@yahoo.com and dr.mehrabi@yums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)