Comparison of the success rate of the percutaneous nephrolithotomy for nonopac kidney stones with two mehtods; fluoroscopic vs ultrasound guided : a randomized clinical trial
A randomized clinical trial to compare the success rate of non opacity kidney stones surgery with two fluoroscopic and ultrasound methods
Design
Two arm parallel group randomized trial, tree blinded, sample size is 42
Settings and conduct
1-The study is being conducted at Bahonar Hospital in Kerman Province.
2-Participants and outcome assessors and data analysts were not aware of either patient's ultrasound or fluoroscopy status.Each patient is randomly assigned to a group after anesthesia.The outcome assessor and analysts have access to all data except the patient placement group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:non opacitty kidney stones;All patients with staghorn,calyceal or pelvic stone who are candidate for percutaneus nephrolithotomy.
non-inclusion criteria:Under 12 years of age;uncorrected coagulation disorder;active urinary tract infection.
Intervention groups
Intervention group 1:sonography:With the guidance of ultrasound in the transverse section, the Shiba needle enters the pelvis.
Intervention group 2:fluoroscopy:After retrograde injection of the contrast and obsevation of pelvis, the shiba needle is inserted.
Department of urology, Kerman University of Medical sciences (KMU)
Country
Iran (Islamic Republic of)
Phone
+98 34 3244 8777
Email address
h_pakmanesh@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the success rate of the percutaneous nephrolithotomy for nonopac kidney stones with two mehtods; fluoroscopic vs ultrasound guided : a randomized clinical trial
Public title
Comparison between sonographic and flouroscopic guided PCNL in renal stone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non opacity kidney stones
All patient with staghorn, calyceal or pelvic stone who are candidate for percutaneus nephrolithotomy (PCNL)
Exclusion criteria:
Under 12 years of age
uncorrected coagulation disorder
active urinary tract infection
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple.
Randomization tool: magic hat statistical software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants and outcome assessors and data analysts were not aware of either patient's ultrasound or fluoroscopy status.Each patient is randomly assigned to a group after anesthesia.The outcome assessor and analysts have access to all data except the patient placement group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
At the beginning of Ebne Sina street, At the beginning of Jahad street, Somayeh intersection
City
Kerman
Province
Kerman
Postal code
7618778584
Approval date
2020-02-29, 1398/12/10
Ethics committee reference number
IR.KMU.REC.1398.080
Health conditions studied
1
Description of health condition studied
Renal stone
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
Residual stone
Timepoint
after surgery during one month period
Method of measurement
physician visit based on computed tomograghy scan (CT scan)
Secondary outcomes
1
Description
Surgical complications
Timepoint
At the time of hospitalization after surgery
Method of measurement
physician visit based on Clavien classification
Intervention groups
1
Description
Sonography group:Under the guidance of ultrasound in the transverse section,the Shiba needle enters the pelvis, and other stages of percutaneous nephrolithotomy are performed.
Category
Treatment - Surgery
2
Description
Fluoroscopic group:After retrograde injection of the contrast and observation of pelvis, the Shiba needle is inserted and other stages of percutaneous nephrolithotomy are performed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Shahid Bahonar hospital
Full name of responsible person
Siavash Vejdani
Street address
Bahrololum street
City
Kerman
Province
Kerman
Postal code
7618778584
Phone
+98 34 3425 4828
Email
Siavj@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Dr Abbas Pardakhti
Street address
Tahmasab Abad intersection
City
Kerman
Province
Kerman
Postal code
7618778584
Email
siavj@yahoo.com
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, Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Siavash Vejdani
Position
Resident in training in Urology
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Bahrololum street
City
Kerman
Province
Kerman
Postal code
7618778584
Phone
+98 34 3425 4828
Email
siavj@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of urology, Kerman university of medical sciences (KMU)
Full name of responsible person
Dr Hamid Pakmanesh
Position
Assistant professor, Endourologist
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Shahid Qarani street
City
Kerman
Province
Kerman
Postal code
7618778584
Phone
+98 34 3223 9188
Fax
+98 34 3223 9188
Email
h_pakmanesh@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Siavash Vejdani
Position
Assistant of urology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Bahrololum street
City
Kerman
Province
Kerman
Postal code
7618778584
Phone
+98 34 3425 4828
Email
siavj@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes can be shared
When the data will become available and for how long
Access period 6 months after the results are published
To whom data/document is available
Everyone
Under which criteria data/document could be used
Used in a similar study
From where data/document is obtainable
Project general officer: Siavash Vejdani, Cellphone number: 09363721535; Email: siavj@yahoo.com
What processes are involved for a request to access data/document
Send e-mail to the given email address and send the full details of the new study