Comparison of success rate and complications of mini PCNL with
ESWL in treatment of lesser than 2cm lower pole kidney stones.
Design
Example 4: A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 501 patients, enrolled between October 2008 and September 2012, and followed for one year
Settings and conduct
khuzetan,Emam hospital,clinical trial
Participants/Inclusion and exclusion criteria
inclusion criteria:
Kidney stones are less than 2 cm in the lower calyx renal.
age of patients is betwwn 18 to 65 years old
Exclusuion criteria:
Patients with a history of coagulation disorders.
The patient has an active urinary tract infection.
Women who are pregnant
Intervention groups
group A: Patients will be treated with direct access to mini PNL method utilized inferior Cullis
group B: Patients will be treated with standard ESWL method.
Main outcome variables
BMI,Hb drop,hospital stay,stone free rate,stone opacity,kind of theraputic procedure,satisfaction of patient,SFR time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190219042765N1
Registration date:2019-04-05, 1398/01/16
Registration timing:registered_while_recruiting
Last update:2019-04-05, 1398/01/16
Update count:0
Registration date
2019-04-05, 1398/01/16
Registrant information
Name
Mahbubeh Saleh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3337 3033
Email address
mbbslh1397@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-29, 1398/01/09
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of success rate and complications of mini PCNL withESWL in treatment of <2cm lower pole kidney stones
Public title
Effect of mini Nephrolithotomy and Lithotriptor in treatment of kidney stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Kidney stones are less than 2 cm in the lower calyx renal.
age of patients is betwwn 18 to 65 years old.
Exclusion criteria:
Patients with a history of coagulation disorders.
The patient has an active urinary tract infection.
Women who are pregnant.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the 4-block method, individuals will be divided randomly into two equal groups.
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 Ahvaz Jundishapur University of Medical Sciences.
Street address
Golestan Blvd
City
ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2019-02-15, 1397/11/26
Ethics committee reference number
IR.AJUMS.REC.1397.850
Health conditions studied
1
Description of health condition studied
renal stone
ICD-10 code
N20.0
ICD-10 code description
Calculus
Primary outcomes
1
Description
Time of Hospitalization
Timepoint
The duration of treatment
Method of measurement
The duration of hospitalization
2
Description
Time of free of stone
Timepoint
24 and 48 hours after surgery
Method of measurement
With clinical examination
Secondary outcomes
1
Description
Hemoglobin decline
Timepoint
24 and 48 hours after surgery
Method of measurement
With laboratory examination
Intervention groups
1
Description
Intervention group: Patients will be treated with direct access to mini PNL method utilized inferior Cullis group
Category
Treatment - Surgery
2
Description
Intervention group: Patients will be treated with standard ESWL method.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hospital
Full name of responsible person
Mahbobeh Saleh
Street address
Shahid ahvazian stress
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3222 2818
Email
mbbslh1397@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohamadreza Dadfar
Street address
Golestan street, Shahr Daneshgahi, Deputy of Research and Technology Development of Ahvaz Jondishapur University of Medical Sciences, Ahvaz.
City
ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?