The aim of the study: Comparative evaluation between ultrasound guided and fluoroscopy guided renal access in PCNL Design of study: Randomized clinical trial, single blind, controlled with standard fluoroscopy, a single central. The study population: Inclusion criteria: each patient who is referred to the Shahid Beheshti hospital and that is candidate for surgical treatment of kidney stones through the skin between 2012-2014. Exclusion criteria: the underlying disease; renal failure; children under 15 years and severe obesity BMI> 35. Sample size: 64 patients in 2 groups of 32 persons. The intervention: access to the kidney using ultrasound. Time intervention: Before surgery. Study outcomes: reduced intraoperative complications and reduce the amount of radiation to the surgeon and patient
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204229534N1
Registration date:2012-05-02, 1391/02/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-05-02, 1391/02/13
Registrant information
Name
Esmaeil Gol Mahmoudi
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 4864
Email address
e.golmahmoudi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2013-01-10, 1391/10/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation between ultrasound guided and fluoroscopy guided renal access in PCNL
Public title
Renal access with ultrasonic guide in renal stone operation
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Each patient who is referred to the Shahid Beheshti hospital and that is candidate for surgical treatment of kidney stones through the skin between 2012-2014.
Exclusion criteria: The underlying disease; Renal failure; Children under 15 years and Severe obesity BMI> 35.
Age
From 15 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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
Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences. Mahdiye st
City
Hamedan
Postal code
6517838736
Approval date
2012-01-05, 1390/10/15
Ethics committee reference number
پ/16/35/9/3587
Health conditions studied
1
Description of health condition studied
Calculus of kidney
ICD-10 code
N20.0
ICD-10 code description
Nephrolithiasis NOS
Primary outcomes
1
Description
Reduce the amount of radiation to the surgeon
Timepoint
During the intervention
Method of measurement
Seconds, using a stopwatch
2
Description
Reduce the amount of radiation to the patient
Timepoint
During the intervention
Method of measurement
Seconds, using a stopwatch
3
Description
Reduce operating costs
Timepoint
After the operation
Method of measurement
The operation cost
4
Description
Reduce intraoperative complications
Timepoint
After the operation
Method of measurement
Surgeon's idea
Secondary outcomes
1
Description
Ultrasounds failure
Timepoint
During the operation
Method of measurement
Surgeon's idea
Intervention groups
1
Description
Intervention group: Patient is positioned in prone situation; Then an ultrasound is performed to see the position of the calices and stones in the kidney and also large vesseles. With the nephrostomy needle under the ultrasound guidance, access to appropriate Calice will be done. Doppler ultrasound exam can help to prevent damage to large vessels.
Category
Other
2
Description
Control group: With the standard methods and with fluoroscopic assistance caliceal access will be achieved.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedans Shahid Beheshti hospital
Full name of responsible person
Street address
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Heydar Tavilaani
Street address
Vice chancellor for research and Technology. Hamedan University of Medical Sciences. Mahdiye st
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Hamid Shayani Nasab
Position
Endourologist / Assistant professor of university
Other areas of specialty/work
Street address
Medical faculty. Hamedan University of Medical Sciences.
City
Hamedan
Postal code
Phone
+98 81 1826 8846
Fax
Email
shayani_nasab@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hamid Shayani Nasab
Position
Endourologist
Other areas of specialty/work
Street address
Medical faculty. Hamedan University of Medical Sciences.
City
Hamedan
Postal code
Phone
+98 81 1826 8846
Fax
Email
shayani_nasab@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Esmaeil Gol Mahmoudi
Position
Medical Student / Student
Other areas of specialty/work
Street address
N. 101. Isar area. Qanizadiyan blv. Ostadan area. Saeidiyey st. Hamedan
City
Hamedan
Postal code
Phone
+98 81 1822 4864
Fax
+98 81 1838 0208
Email
e.golmahmoudi@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)