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The comparison of operative time and results in patients who undergo percutaneous nephrolithotomy with and without splitting amplatz sheath

Protocol summary

Summary
The objective of the present study is to determine the impact of splitting amplatz sheath on the operative time.Design: First for the pilot study, 10 patients were chosen and with their full consent, they underwent Percutaneous Nephrolithotomy with and without splitting Amplatz sheath. After assessing and making sure of the primary results, a not blinded randomized clinical trial was designed. Method: Patients are randomly divided into two groups of 36. The first group undergoes Percutaneous Nephrolithotomy with longitudinal split in Amplatz sheath, while for the second group, Amplatz sheath is kept intact. Operative time, fluoroscopic time, hemoglobin decline and residual stone will be compared between the two groups. Inclusion criteria: Patients who are candidate for Percutaneous Nephrolithotomy with kidney stones larger than 2cm in diameter or stones resistant to extracorporeal shock wave lithotripsy (ESWL). Exclusion criteria: Patients with multiple stones, cardiac problems, liver or renal failure and supine position. Intervention:The first group undergoes Percutaneous Nephrolithotomy with longitudinal split in Amplatz sheath , while for the other group Amplatz sheath is kept intact. Main outcome measures (variables): Operative time, fluoroscopic time, and residual stone.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111187457N7
Registration date: 2013-06-26, 1392/04/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-26, 1392/04/05
Registrant information
Name
Shabnam Golshan
Name of organization / entity
Urology and Nephrology Research Center (UNRC)
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 7222
Email address
shgolshan@unrc.ir
Recruitment status
Recruitment complete
Funding source
This project will be supported by Urology and nephrology research center related to Shahid Behshti university of Medical sciences.
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of operative time and results in patients who undergo percutaneous nephrolithotomy with and without splitting amplatz sheath
Public title
The impact of longitudinal splitting of Amplatz sheath on the results of Percutaneous Nephrolithotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who are candidate for Percutaneous Nephrolithotomy with kidney stones larger than 2cm in diameter or stones resistant to extracorporeal shock wave lithotripsy (ESWL). Exclusion criteria: Patients with multiple stones, cardiac problems, liver or renal failure and supine position.
Age
From 10 years old to 80 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sampling method is based on Archive number. For even Archive numbers, amplatz sheath was kept intact and for odd numbers, amplatz sheath was split.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of medical sciences ethics committee
Street address
No.103, 9th Boostan St., Pasdaran Ave.,Tehran
City
Tehran
Postal code
1666677951
Approval date
2013-03-12, 1391/12/22
Ethics committee reference number
17/الف/م/ت

Health conditions studied

1

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

Primary outcomes

1

Description
duration of surgery
Timepoint
During surgery
Method of measurement
Length of time between prone position to supine position

2

Description
Duration of Fluoroscopy
Timepoint
during surgery
Method of measurement
Fluoroscope recordings

3

Description
residual stone
Timepoint
one day after surgery
Method of measurement
ultrasonography and plain abdominal x-ray

Secondary outcomes

1

Description
Size of primary stone
Timepoint
Before surgery
Method of measurement
The longest longitudinal side x the longest width side (cm^2)

2

Description
Hemoglobin
Timepoint
one day before surgery,the day after surgery and at discharge time
Method of measurement
Laboratory test (CBC)

Intervention groups

1

Description
Control group: 36 patients undergo Percutaneous Nephrolithotomy using 30 French(f.) Amplatz sheath without splitting.
Category
Treatment - Surgery

2

Description
intervention group:36 patients undergo Percutaneous Nephrolithotomy using 30 French (f.) Amplatz sheath with splitting
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Labbafinejad Medical Center
Full name of responsible person
Ali Tabibi
Street address
No. 99.,9th Boostan St. ,Pasdaran Ave.,Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for research, Shahid Beheshti university of medical sciences
Full name of responsible person
Shahid Beheshti University of medical sciences
Street address
Shahid Arabi st.,Yaman st.,Shahid Chamran Highway,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for research, Shahid Beheshti 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
Shahid Labbafinejad Medical Center
Full name of responsible person
Dr. Amir Reza Abedi
Position
Urologist
Other areas of specialty/work
Street address
No.99, 9th Boostan st., Pasdaran Ave.,Tehran
City
Tehran
Postal code
Phone
+98 21 2258 8016
Fax
Email
arabedi_80@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Labbafinejad Medical Center
Full name of responsible person
Ali Tabibi
Position
Urologist
Other areas of specialty/work
Street address
No.99,9th Boostan st., Pasdaran Ave.,Tehran
City
Tehran
Postal code
Phone
+98 21 2258 8016
Fax
Email
dr.alitabibi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Labbafinejad Medical Center
Full name of responsible person
Amir Reza Abedi
Position
Urologist
Other areas of specialty/work
Street address
No.99, 9th Boostan st., Pasdaran Ave. ,Tehran
City
Tehran
Postal code
Phone
+98 21 2258 8016
Fax
Email
arabedi_80@yahoo.com
Web page address

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
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