Protocol summary

Summary
The objective of this study was to assess the feasibility of one-stage acute dilation of the nephrostomy tract with a 30F Amplatz dilator in patients who are candidate for percutaneous nephrolithotomy (PCNL), regardless of whether there is a previous renal scar to make the procedure less time consuming and more cost effective. One-stage tract dilation for PCNL was done in 100 patients with age more than 16 and kidney stone greater than 2 cm who had been referred to Labafinejad Hospital and were candidates for percutaneous nephrolithotomy (PCNL). Access time and radiation exposure time during access were compared in patients with and without history of ipsilateral open stone surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138803191267N15
Registration date: 2009-08-24, 1388/06/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-08-24, 1388/06/02
Registrant information
Name
Mojgan Borgheie
Name of organization / entity
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University of Mediacal Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 7222
Email address
research@unrc.ir
Recruitment status
Recruitment complete
Funding source
Urology and Nephrology Research Center ( UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.R. Iran
Expected recruitment start date
2007-03-21, 1386/01/01
Expected recruitment end date
2009-03-21, 1388/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of one step tract dilatation for percutaneus nephrolithotripsy in patient with and without kidney operation.
Public title
Comparison of one step tract dilatation for percutaneus nephrolithotripsy in patient with and without kidney operation.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age more than 16 years, kidney stone greater than 2 cm Exclusion criteria: Presence of UTI, pyonephrosis, or coagulation disorder, no allowance for general anesthesia
Age
From 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Urology and Nephrology Research Center ( UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.
Street address
UNRC, No.101,9th Boostan St., Pasdaran Ave., Tehran, I.R. Iran
City
Tehran
Postal code
1666677951
Approval date
2005-02-09, 1383/11/21
Ethics committee reference number
71

Health conditions studied

1

Description of health condition studied
kidney stone
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney

Primary outcomes

1

Description
Access time
Timepoint
during surgery
Method of measurement
Time of access in minutes

Secondary outcomes

1

Description
X-RAY exposure time
Timepoint
During surgery
Method of measurement
ARM-C

2

Description
Bleeding complications
Timepoint
during surgery
Method of measurement
Bleeding volume in cc

Intervention groups

1

Description
Access in patients under percutaneus nephrolithotripsy and with or without previuos scar
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Labafi Nejad Hospital
Full name of responsible person
Dr Seyed Amir Mohsen Ziaee
Street address
Labafi Nejad Hospital.,9th Boostan St., Pasdaran Ave., Tehran, I.R. Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urology and Nephrology Research Center ( UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran,
Full name of responsible person
Shabnam Golshan
Street address
UNRC, No.101, Boostan 9th St., Pasdaran Ave., Tehran, I.R. Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology and Nephrology Research Center ( UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran,
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 and Nephrology Research Center (UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.R.
Full name of responsible person
Dr Seyed Amirmohsen Ziaee
Position
Associate Professor
Other areas of specialty/work
Street address
UNRC, No.101,9th Boostan St., Pasdaran Ave., Tehran, I.R. Iran
City
Tehran
Postal code
1666677951
Phone
+98 21 2256 7222
Fax
+98 212277954
Email
Research @unrc.ir
Web page address
www.unrc.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urology and Nephrology Research Center ( UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.R
Full name of responsible person
Dr Seyed Amirmohsen Ziaee
Position
Associate professor
Other areas of specialty/work
Street address
UNRC, No.101, 9th Boostan St., Pasdaran Ave., Tehran, I.R. Iran
City
Tehran
Postal code
1666677951
Phone
+98 21 2256 7222
Fax
+98 212277954
Email
Research @unrc.ir
Web page address
www.unrc.ir

Person responsible for updating data

Contact
Name of organization / entity
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.R.
Full name of responsible person
Dr Mozhgan Borgheie
Position
MD
Other areas of specialty/work
Street address
UNRC, No.101, Boostan 9th St., Pasdaran Ave., Tehran, I.R. Iran
City
Tehran
Postal code
1666677951
Phone
+98 21 2256 7222
Fax
+98 212277954
Email
borgheie@unrc.ir
Web page address
www.unrc.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...