The purpose of the study:
The purpose of the study is assessing the outcome of blind PCNL and its related effective factors, and then, making a comparison with fluoroscopic-guided PCNL. The main inclusion criteria is presence of Stag-horn renal calculus and the main exclusion criteria is presence of Blood coagulation disorders. We will study 100 patients with kidney stones, who are referred to Shohadaye Tajrish Hospital and are candidates for PCNL. In order to carry out this study, patients will be randomly divided into two equal groups. Blind PCNL in one group and fluoroscopic-guided PCNL in another group will be carried out. Blind PCNL through anatomic landmark, namely lumbar notch, will be carried out. An 18-gauge needle will be inserted with an angle of 30 degrees through skin in the notch area below the 12th rib and will be advanced to the depth of 3-4 cm until it arrives at calyx. The background variables and demographic information will be recorded for each patient. At the end of the operation, KUB and sonography are performed to determine the urinary residue. In addition, in blind PCNL, all cases of punctures and the access locations will be determined by fluoroscopy. Moreover, puncture numbers will be calculated at the end of surgery and surgery complications like hematoma will be determined by sonography.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138803121267N9
Registration date:2009-08-17, 1388/05/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-08-17, 1388/05/26
Registrant information
Name
Mojgan Borgheie
Name of organization / entity
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University of Mediacal Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 7222
Email address
research@unrc.ir
Recruitment status
Recruitment complete
Funding source
Urology and Nephrology Research Center ( UNRC), Shahid Beheshti University,
Expected recruitment start date
2007-02-20, 1385/12/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An assessment of blind PCNL outcomes and the related effective factors and a comparison of the outcomes with the fluoroscopic-guided PCNL
Public title
An assessment of blind PCNL outcomes and the related effective factors and a comparison of the outcomes with the fluoroscopic-guided PCNL
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of stag-horn renal calculus, caliceal stone with hydronephrosis, or impacted superior ureteral stone, written informed consent
Exclusion criteria: More than 5 punctures, Presence of scar, previous operation, Skin infection at the surgical site, presence of blood coagulation disorders
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
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
Urology and Nephrology Research Center ( UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.