To assess the outcome and safety of the totally tubeless percutaneous nephrolithotomy (PCNL) in compare with standard PCNL in the children under 14 years old.
Twenty three patients with upper pole renal stones were enrolled in a prospective randomized clinical trial during July 2010 to Jan 2012. The inclusion criteria were patient age less than 14 years old; existence of stone size >2.5 cm; stone resistant to the extracorporeal shockwave lithotripsy (SWL); furthermore, exclusion criteria were serious bleeding; perforation in the collecting system during the operation; kidney anomalies; renal failure on admission. The patients were divided into two groups. Totally tubeless percutaneous nephrolithotomy was performed on one group while, patients in another group underwent standard procedure. The incidence of complications, hospital stay, transfusion rate, stone free rate and analgesic use were compared between the two groups during a 1-month study period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110017675N1
Registration date:2011-10-08, 1390/07/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-08, 1390/07/16
Registrant information
Name
Mehdi Aloosh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8556
Email address
m_aloosh@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2010-07-01, 1389/04/10
Expected recruitment end date
2011-12-31, 1390/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing efficacy and safety of conventional and totally tubeless percutaneous nephrolithotomy in under 14 year-old patients; a clinical trial
Public title
Comparing efficacy and safety of conventional and totally tubeless percutaneous nephrolithotomy in under 14 year-old patients; a clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria were patient age less than 14 years old; the existence of stone size >2.5 cm; stone resistant to extracorporeal shockwave lithotripsy (SWL).
The exclusion criteria were serious bleeding; perforation in the collecting system during the operation; kidney anomalies; renal failure on admission.
Age
To 14 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences' ethical committee
Street address
Tehran University of Medical Sciences, Enghelab St.