Clinical trial of study the effects of Extracorporeal shock wave lithotripsy in simple renal cyst formation in patients with renal stone with age under 35 years old
The objective of this study is to identify the connection between Extracorporeal Shock wave Lithotripsy (ESWL) and formation of renal cyst in short term. The link between the amount of energy of the shock waves and the number of induced shocks to each kidney will also be studied in this research. This study will be conducted on patients who have been diagnosed with renal stone at Behboud Hospital`s Lithotripsy Center. In this study, 30 patients, under the age of 35, who have been diagnosed with unilateral renal stone and have no history of renal cyst are chosen as the intervention group and the opposite kidney of the same group of patients is considered as the control group. The main inclusion criteria for this study are: Patients who have been diagnosed with unilateral Renal stone and need to do ESWL; without any history of renal cyst; age under 35 years old. Also, the main exclusion criteria are: any other medical treatment other than ESWL for Renal stone; History of renal cyst; age above 35 years old. Before ESWL, Sonography will be performed to ensure absence of renal cyst. During the next step, patients will receive ESWL treatment, and the number of induced shock waves and the amount of energy entered to each kidney during each treatment will be recorded. Both kidneys will be studied in 9 months by performing sonography to identify the possibility of cyst formation and the size of the renal stone.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607179904N2
Registration date:2016-09-22, 1395/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-22, 1395/07/01
Registrant information
Name
Mohsen Amjadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 411584153
Email address
amjadm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Researcher
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-07-21, 1394/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of study the effects of Extracorporeal shock wave lithotripsy in simple renal cyst formation in patients with renal stone with age under 35 years old
Public title
Study the effects of lithotripsy in renal cyst formation
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion Criteria: Patients who have been diagnosed with unilateral kidney stone and need to do Lithotripsy; without any history of renal cyst; age under 35 years old
Exclusion Criteria: Any other medical therapy other than Lithotripsy for kidney stone; History of kidney cyst; age above 35 years old
Age
To 35 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Central Building, Tabriz University of medical Science, Golgasht St.
City
Tabriz
Postal code
Approval date
2015-07-27, 1394/05/05
Ethics committee reference number
TBZMED.REC.1394.400
Health conditions studied
1
Description of health condition studied
Renal Stone
ICD-10 code
N20
ICD-10 code description
Calculus of kidney
2
Description of health condition studied
Renal Cyst
ICD-10 code
N28.1
ICD-10 code description
Cyst of kidney, acquired
Primary outcomes
1
Description
Simple Renal Cyst Formatiom
Timepoint
9 month after ESWL
Method of measurement
Sonography
2
Description
The amount of energy received by each kidney in each session
Timepoint
During ESWL
Method of measurement
Questionnaire
3
Description
The number of shock waves received by each kidney in each session
Timepoint
During ESWL
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Size of renal stone after ESWL
Timepoint
9 month after ESWL
Method of measurement
Sonography
Intervention groups
1
Description
Control Group : No action
Category
N/A
2
Description
Interventionl Group : Extracorporeal shock wave lithotripsy done for 20 minutes on target kidney.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Behboud Hospital`s Lithotripsy Center
Full name of responsible person
Ali Azari
Street address
Southern army Street, Cross Baghshmal
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Elham Azari
Street address
Faculty of Medicine, Tabriz University of Medical Science, Golgasht Street
City
Tabriz
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 of Tabriz University of Medical Sciences