Comparison of complications and outcomes in the two techniques of percutaneous nephrolithotomy using ultrasonography and fluoroscopy guidance in the patients referring to Razi hospital- 2009
The purpose of this study was to compare complications and outcomes of the two techniques of percutaneous nephrolithotomy under ultrasonography and fluoroscopy guidance. In this survey, 50 patients with nephrolithiasis were randomly assigned in 2 different groups to be operated by PCNL. The PCNL were performed under guidance of sonography or fluoroscopy. After 2 weeks, all the patients were evaluated for the complications and stone residues and the results was compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138805251853N3
Registration date:2011-02-26, 1389/12/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-26, 1389/12/07
Registrant information
Name
Siavash Falahatkar
Name of organization / entity
Urology Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 3352 5259
Email address
urc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Assistant of Guilan University of Medical Sciences
Expected recruitment start date
2009-01-20, 1387/11/01
Expected recruitment end date
2010-01-21, 1388/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of complications and outcomes in the two techniques of percutaneous nephrolithotomy using ultrasonography and fluoroscopy guidance in the patients referring to Razi hospital- 2009
Public title
Comparison of complications and outcomes in the two techniques of percutaneous nephrolithotomy using ultrasonography and fluoroscopy guidance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of single pelvic stones, single calyceal stones, kidneys with stones in the pelvis and lower calyx, upper ureteral stones, kidneys with non-opaque stones, previous open surgery. Exclusion criteria: Presence of multiple stones, ectopic kidneys or opaque staghorn stones, stone in upper calyx, immunodeficiency
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Guilan University of Medical Sciences
Street address
Guilan University of Medical Sciences
City
Rasht
Postal code
41448-95655
Approval date
2009-08-26, 1388/06/04
Ethics committee reference number
4091
Health conditions studied
1
Description of health condition studied
Urolithiasis
ICD-10 code
N20, N23
ICD-10 code description
Urolithiasis
Primary outcomes
1
Description
stone free rate
Timepoint
2 weeks
Method of measurement
sonography, KUB
2
Description
need to transfusion
Timepoint
during operation, 48 hours after operation
Method of measurement
measuring hemoglobin
3
Description
colon injury
Timepoint
during operation, 48 hours after operation
Method of measurement
inspection of stool at skin puncture, fistula formation at the skin puncture
4
Description
operation time
Timepoint
during operation
Method of measurement
minute
Secondary outcomes
1
Description
fever
Timepoint
24 hours after operation
Method of measurement
thermometer
Intervention groups
1
Description
Ultrasonic guided Percutaneous Nephrolithotomy
Category
Treatment - Surgery
2
Description
Floroscopic guided Percutaneous Nephrolithotomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr Siavosh Falahatkar
Street address
Sardar Jangal street, Razi Hospital
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Assistance of Guilan University of Medical Sciences
Full name of responsible person
Dr Abdolrasoul Sobhani, Research Assistant of Guilan University of Medical Sciences
Street address
Guilan University of Medical Sciences
City
Rasht
Grant name
معاونت پژوهشي دانشگاه علوم پزشکی و خدمات بهداشتی و درمانی گیلان
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistance of Guilan 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
Urology Research Center
Full name of responsible person
Dr Majid Kazemzadeh
Position
Co worker/Resident
Other areas of specialty/work
Street address
Razi Hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
urc@gums.ac.ir
Web page address
www.urc.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr Siavosh Falahatkar
Position
Professor
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
falahatkar_s@yahoo.com
Web page address
www.urc.ir
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr Allahkhah Aliakbar
Position
General Practitioner - Manager of Urology Research Center
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
allahkhaha@yahoo.com
Web page address
www.urc.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)