Protocol summary

Summary
Our aim was to evaluate the safety and efficacy of percutaneous nephrolithotomy (PCNL) with ultrasonography (US)-guided renal access in the lateral decubitus flank position in comparison with prone position. 80 patients of Shohadaye Tajrish hospital who were candidates of PCNL and had renal stone larger than 2 centimeter and had not uncontrolled coagulopathy were randomly allocated to undergo Percutancous nephrolithotomy with US-guided renal access in lateral decubitus flank position or in prone position. Surgery time, anesthesia complications, ABG results, bleeding and damage to kidney were compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138803131267N10
Registration date: 2009-08-17, 1388/05/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-08-17, 1388/05/26
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
2007-02-20, 1385/12/01
Expected recruitment end date
2008-02-20, 1386/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Percutaneous nephrolithotomy with ultrasonography-guided renal access in the lateral decubitus flank position.
Public title
Percutaneous nephrolithotomy with ultrasonography-guided renal access in the lateral decubitus flank position.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of kidney stone greater than 2 cm, candidate for Percutaneous nephrolithotomy (PCNL), Exclusion criteria: kidney anomalous, uncontrolled coaguloathy, history of previous PCNL or open renal stone surgery
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
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
2007-01-28, 1385/11/08
Ethics committee reference number
75

Health conditions studied

1

Description of health condition studied
kidney stone
ICD-10 code
N20.1
ICD-10 code description
Ureteric stone

Primary outcomes

1

Description
duration of surgery
Timepoint
during surgery
Method of measurement
Duration of surgery in minutes

2

Description
Complications of anesthesia
Timepoint
during and after surgery
Method of measurement
phisical exam

Secondary outcomes

1

Description
Arterial hypoxia
Timepoint
after surgery
Method of measurement
Arterial Blood Gas tests

2

Description
Bleeding
Timepoint
during surgery
Method of measurement
Volume of blood lost in cc

3

Description
Damage to kidney
Timepoint
during surgery
Method of measurement
physical examination

Intervention groups

1

Description
PCNL in lateral decubitus position
Category
Treatment - Surgery

2

Description
PCNL with guide of floroscopy in prone position
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Street address
Shohadaye Tajrish Hospital, Shriati Ave,Tajrish Sq.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University,
Full name of responsible person
Shabnam Golshan
Street address
UNRC, No.101, 9th Boostan 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,
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 of Medical Sciences
Full name of responsible person
Alireza Rezaee
Position
Resident of urology
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 22 77954
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, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossein Karami
Position
Professor
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
Research @unr c.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 of Medical Sciences
Full name of responsible person
Mozhgan Borgheie
Position
MD
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 22567222
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...