Objectives: To assess compare standard and tubeless intercostal percutaneous nephrolithotomy in patients with kidney stone.
Design: A single blind randomized clinical trial.
Setting and conduct: The eligible patients with kidney stone who will refer to Besat Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 65 years; stone with a diameter of more than 1 cm in the lower calyx; stone with a diameter of more than 2 cm in the upper and middle calyx and the pelvis; a stone with a diameter of more than 1 cm in the upper urethra.
Exclusion criteria: A previous history of kidney surgery.
Intervention group: Tubeless intercostal percutaneous nephrolithotomy.
Control group: Standard intercostal percutaneous nephrolithotomy.
Primary outcome: (a) amount of analgesic usage during 72 hours after surgery based on medical document; (b) duration of hospitalization after surgery based on medical document.
Secondary outcome: Side effect of surgery (bleeding, damage to the kidney collecting system, spleen damage, colon damage, major vessel damage and pneumothorax) upon 72 hours after surgery through physical examination.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. Therefore, the trial will be run as single blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201706309014N172
Registration date:2017-07-02, 1396/04/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-02, 1396/04/11
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
2017-07-11, 1396/04/20
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of standard and tubeless intercostal percutaneous nephrolithotomy in patients with kidney stone: A single blind randomized clinical trial
Public title
Comparison of standard and tubeless intercostal percutaneous Kidney stone breaker in patients with kidney stone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 65 years; stone with a diameter of more than 1 cm in the lower calyx; stone with a diameter of more than 2 cm in the upper and middle calyx and the pelvis; a stone with a diameter of more than 1 cm in the upper urethra.
Exclusion criteria: A previous history of kidney surgery.
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:
50
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: Patients will be unaware 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
City
Hamadan
Postal code
6517838695
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.UMSHA.REC.1396.246
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 analgesic usage
Timepoint
during 72 hours after surgery
Method of measurement
based on medical document
2
Description
duration of hospitalization
Timepoint
after surgery upon discharge
Method of measurement
based on medical document
Secondary outcomes
1
Description
Side effect of surgery (bleeding, damage to the kidney collecting system, spleen damage, colon damage, major vessel damage and pneumothorax)