Our aim in this study is to compare nephrostomy tract dilatation between balloon catheter and telescopic technique for percutaneous nephrolithotomy. The key inclusion criteria are to be18 to 70 years old; to have indication for percutaneous nephrolithotomy and the key exclusion criteria is to have a history of flank surgery and multiple nephrostomy tracts. In a randomized single blinded unicentral study patients administered in Emam Reza hospital, Tabriz, Iran and candidate for percutaneous nephrolithotomy will be assinged to receive one of these treatments: in group 1 a 10 to 15 cm length and 10 to 12 mm diameter balloon would be used to dialate the tract and then using a nephroscope and a lithotomy set stone would be broken and extracted from the tract; in group 2 using telescopic technique 8 metal dialators up to Fr27 diameter would be used to dialate the tract and a nephroscope and lithotomy set to break the stones and extract from the tract. To detect any probabale hemorrhage hemoglobin before, 6 and 24 hours after the operation will be checked for all the patients and to detect urine leak or urinoma a sonography and KUB would be performed a day after the operation to compare the results.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205299904N1
Registration date:2012-06-11, 1391/03/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-11, 1391/03/22
Registrant information
Name
Mohsen Amjadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 411584153
Email address
amjadm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the nephrostomy tract dilatation between balloon catheter and telescopic technique for percutaneous nephrolithotomy
Public title
Comparison of nephrostomy tract dilatation using balloon catheter or telescopic technique
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 to 70 years old and having indication for percutaneous nephrolithiotomy. Exclusion criteria: history of flank surgery and multiple nephrostomy tracts and any systemic disease which might affect treatment outcome.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethical Committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Square
City
Tabriz
Postal code
Approval date
2012-05-01, 1391/02/12
Ethics committee reference number
5/41396
Health conditions studied
1
Description of health condition studied
Nephrolithiasis
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
Blood hemoglobin level
Timepoint
Before, 6 and 24 hours after the operation
Method of measurement
Labratory (mg/dl)
2
Description
Number of residual stones
Timepoint
One day after the operation
Method of measurement
Using sonography and KUB
3
Description
Urine leak
Timepoint
6 hours after the operation
Method of measurement
Sonography
4
Description
Urinoma
Timepoint
6 hrs after the operation
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
For ballon group: to dialate the tract a 10 to 15 cm length and 10 to 12 mm diameter balloon would be used. Then using a nephroscope and nephrolithotomy set stones would be broken and extracted from the tract.
Category
Treatment - Surgery
2
Description
For telescopic group: 8 metal dialators up to Fr27 diameter would be used to dialate the tract and a nephroscope and lithotomy set to break the stones and extract from the tract
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Arash Nouri
Street address
Imam Reza hospital, Golgasht st.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Vce chancellor for research, Tabriz University of Medical Sciences, Daneshgah square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Arash Nouri
Position
MD, Urolgy resident
Other areas of specialty/work
Street address
Urology ward, Imam Reza hospital, Golgasht st.
City
Tabriz
Postal code
Phone
+98 41 1658 4153
Fax
Email
mehdi.hemmati@rocketmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohsen Amjadi
Position
Associate professor/ Urologist
Other areas of specialty/work
Street address
Imam Reza hospital, Golgasht st.
City
Tabriz
Postal code
Phone
+98 41 1658 4153
Fax
Email
amjadm@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arash Nouri
Position
MD, Urology rsident
Other areas of specialty/work
Street address
Urology ward, Imam Reza hospital, Golgasht st.
City
Tabriz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)