Comparison of the treatment effect of percutaneous nephrolithotomy access to pyelocalyceal system through ultrasonography versus fluoroscopy in patients with kidney stone: a randomized clinical trial
Objectives: Comparison of the treatment effect of percutaneous nephrolithotomy access to pyelocalyceal system through ultrasonography versus fluoroscopy.
Design: A randomized clinical trial.
Setting and conduct: The eligible patients with kidney stone who will refer to Shahid Beheshti Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 65 years; having kidney stone.
Exclusion criteria: Cardiopulmonary disease; coagulopathy; untreated urinary tract infection; severe obesity with body mass index above35.
Intervention group 1: Percutaneous nephrolithotomy through ultrasonography.
Intervention group 2: Percutaneous nephrolithotomy through fluoroscopy.
Primary outcome: (a) amount of access to pyelocalyceal system through clinical evaluation during surgery; (b) duration of time to access to pyelocalyceal system through clinical evaluation during surgery.
Secondary outcome: (a) hydronephrosis 24 and 48 hours after surgery trough physical examination; (b) amount of bleeding during surgery through measuring volume of suctioned blood.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201704089014N155
Registration date:2017-04-10, 1396/01/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-10, 1396/01/21
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the treatment effect of percutaneous nephrolithotomy access to pyelocalyceal system through ultrasonography versus fluoroscopy in patients with kidney stone: a randomized clinical trial
Public title
Comparison of the treatment effect of percutaneous nephrolithotomy access to pyelocalyceal system through ultrasonography versus fluoroscopy in patients with kidney stone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 65 years; having kidney stone.
Exclusion criteria: Cardiopulmonary disease; coagulopathy; untreated urinary tract infection; severe obesity with body mass index above35.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2017-01-14, 1395/10/25
Ethics committee reference number
IR.UMSHA.REC.1395.443
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
amount of access to pyelocalyceal system
Timepoint
during surgery
Method of measurement
through clinical evaluation
2
Description
duration of time to access to pyelocalyceal system
Timepoint
during surgery
Method of measurement
through clinical evaluation
Secondary outcomes
1
Description
hydronephrosis
Timepoint
24 and 48 hours after surgery
Method of measurement
trough physical examination
2
Description
amount of bleeding
Timepoint
during surgery
Method of measurement
through measuring volume of suctioned blood
Intervention groups
1
Description
Intervention group 1: Percutaneous nephrolithotomy through ultrasonography.
Category
Treatment - Surgery
2
Description
Intervention group 2: Percutaneous nephrolithotomy through fluoroscopy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Poya Parsi
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 and Technology, Hamadan 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 Beheshti Hospital
Full name of responsible person
Dr Poya Parsi
Position
Resident of Urology
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
pouyaparsi6699@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Sasan Mehrabi
Position
Urologist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
mehrabi.sasan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)