Comparison of the adverse effect of standard percutaneous nephrolithotomy versus & tubeless percutaneous nephrolithotomy in patients having kidney stone: a single blinded randomized controlled trial
Objectives: To compare the adverse effect of standard percutaneous nephrolithotomy versus & Tubeless percutaneous nephrolithotomy in patients having kidney stone.
Design: .a single blind randomized clinical trial.
Setting and conduct: The eligible patients having kidney stone who will refer to Shahid Beheshti Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Kidney stone; age of 18 to 80 years.
Exclusion criteria: Indication of open surgery.
Intervention group: Tubeless percutaneous nephrolithotomy.
Control group: Standard percutaneous nephrolithotomy.
Primary outcome: (a) hemoglobin before and 24 hours after intervention through laboratory testing; (b) hematoma 24 hours after intervention using sonography.
Secondary outcome: Pain 24 hours after surgery using VAS.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: The patients will not be aware of the type of intervention. Therefore, the trial will be run as single blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201611019014N129
Registration date:2016-11-18, 1395/08/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-18, 1395/08/28
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 the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the adverse effect of standard percutaneous nephrolithotomy versus & tubeless percutaneous nephrolithotomy in patients having kidney stone: a single blinded randomized controlled trial
Public title
Comparison of the adverse effect of two methods of nephrolithotomy in patients having kidney stone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Kidney stone; age of 18 to 80 years.
Exclusion criteria: Indication of open surgery.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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: The patients will not be aware of the type of intervention. Therefore, the trial will be run as single blind.
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