in this clinical trial sixty two patients older than 18 years old with renal or upper ureteral stones that were candicated for PCNL and refer to operating room of yasuj Shaheed Beheshti hospital from 2012 April to 2013 march after taking informed consent from them ‚ randomly assigned by 4 block method to one of two groups‚ then in both groups standard PCNL was done under spinal anesthesia with fluoroscopic-guided.
In both groups in absence of any complication after operation patients was transferred to recovery and satisfaction was checked by Beck scale then patients were transferred to ward. In 2th post operative day nephrostomy tube was clumped and if there was no urinary leak, fever and flank pain nephrostomy was removed and patients discharged.two weeks later patients again visit and efficacy of operation checked by KUB and ultra sonography.
All data records and analysed by SPSS software and chi square and T student Tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410261323N7
Registration date:2014-11-09, 1393/08/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-09, 1393/08/18
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
vice-Chancelor for Research, Yasuj University of Medical Sciences and Health Services
Expected recruitment start date
2012-04-01, 1391/01/13
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, complications and patient satisfaction from PCNL in prone and supine position under spinal anesthesia
Public title
prone versus supine pcnl
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Age more than 18 years, presence of renal or upper ureteral stone, candidate for PCNL (multiple stones, staghorn stones, calyceal diverticule stones, stone which are resistant to ESWL, lower pole renal stone larger than >15 mm and other renal stone larger than 25 mm, upper ureteral stone >20mm, Having informed consent
Exclusion criteria: Any contraindication for regional anesthesia, presence of coagulopathy, acute infection ore urosepsis, presence of acute renal failure
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
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
Mottahari street,Yasuj University of Medical Sciences
City
Yasuj
Postal code
7591741417
Approval date
2012-08-18, 1391/05/28
Ethics committee reference number
p/23/7/2834
Health conditions studied
1
Description of health condition studied
Renal and ureteral stones
ICD-10 code
N20.2
ICD-10 code description
Calculus of kidney with calculus of ureter
Primary outcomes
1
Description
Success rate of operation
Timepoint
during operation and two week later
Method of measurement
observation by nephroscope and fluroscopy during operation and with sonography and KUB two weeks later
Secondary outcomes
1
Description
satisfaction of patients
Timepoint
during and after operation
Method of measurement
Beck scale of satisfaction rate
2
Description
Any complications of surgery
Timepoint
during operation to two week later
Method of measurement
eport of patients and observation with examination of patients
Intervention groups
1
Description
Performing PCNL under spinal anesthesia at the prone position
Category
Treatment - Surgery
2
Description
Performing PCNL under spinal anesthesia at the supine position
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
Yasyj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research manager, Yasuj University of Medical Sciences
Full name of responsible person
Dr Mehdi Akbartabar
Street address
Mottahari street, Research manager, 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
Research manager, Yasuj 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
Yasuj university of medical science
Full name of responsible person
Dr Sadrollah Mehrabi
Position
professor. Chairman of urology department,Yasuj university of medical science
Other areas of specialty/work
Street address
Education vice chancellor,Yasuj University of Medical Sciences, Motahari street
City
Yasuj
Postal code
Phone
+7 433346070
Fax
Email
sadrollahm@yahoo.com and dr.mehrabiyums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj university of medical science
Full name of responsible person
Dr Sadrollah Mehrabi
Position
Associate professor, Fellowship of Endourology, Urology Department, Yasuj University of Medical Scie
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Motahari street,
City
Yasuj
Postal code
Phone
+7 433346070
Fax
Email
dr.mehrabi@yums.ac.irsadrollahm@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr Sadrollah Mehrabi
Position
professor, subspeciallity of Endourology, Urology Department, Yasuj University of Medical Sciences
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Motahari street,
City
yasuj
Postal code
Phone
00
Fax
Email
sadrollahm@yahoo.com and dr mehrabiyums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)