Comparison of efficacy and complications of tubeless Percutaneous Nephrolithotomy in prone and supine position under spinal anesthesia in adult patients
In this randomized clinical trial 64 patients aged18 years and over with renal or upper ureteral stones candidate for percutaneous nephrolithotomy(PCNL) that refer to Shahid Beheshti hospital of Yasuj after taking informed consent form and approval of ethics committee randomly assigned in one of two groups to undergo surgery in supine or prone position . Patients with severe cardiovascular or pulmonary disease, uncontrolled coagulopathy, pregnant patients and those with any contraindication for general or spinal anesthesia will excluded. Basic serum samples including Hb and kidney function tests (BUN, Cr), urinalysis and urine culture will be checked for all of them. Then in Group 1 (prone position) after prep of patients under spinal anesthesia (2-2.5 milliliter of bupivacaine and 0.5 milliliter of fentanyl) ureteral catheter 5-6F will be inserted in ureter in the lithotomy position .Then the patient position will be changed in prone position and with fluoroscopic guidance PCNL will performed using standard methods without nephrostomy tube. In second group (Supine position) under spinal anesthesia similar to the first group and after inserting ureteral catheter PCNL will be done same as first group in supine position. In the event of any adverse events operation will be terminated and standard treatment will be done. Twenty four hours after surgery Hb, BUN and Cr will be checked and in absence of fever, urine leakage or any complication patients will be discharged. Two week after surgery the patients visit again and ultrasonography and KUB will be performed for evaluating efficacy,success of operation and complications and data recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509111323N9
Registration date:2016-02-28, 1394/12/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-28, 1394/12/09
Registrant information
Name
Sadrollah Mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3334 6070
Email address
dr.mehrabi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Yasuj University of Medical Sciences
Expected recruitment start date
2015-01-01, 1393/10/11
Expected recruitment end date
2015-10-01, 1394/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and complications of tubeless Percutaneous Nephrolithotomy in prone and supine position under spinal anesthesia in adult patients
Public title
Position and Percutaneous Nephrolithotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with renal or upper ureteral stones more than 15-20 mm aged18 years and over candidate for PCNL( stones resistant to ESWL‚ multiple stones and staghorn kidney stones);
Exclusion criteria: Patients with severe cardiovascular or pulmonary disease, uncontrolled coagulopathy, scoliosis or kyphosis, pregnant patients and those with any contraindication for general or spinal anesthesia
Age
From 18 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
For randomization of patients to one of two groups of interventions block randomization with four block were used.
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ettics committee of Yasuj University of medical sciences
Street address
Mottahari street, Yasuj University of medical sciences, Yasuj, Iran
City
Yasuj
Postal code
Approval date
2014-07-23, 1393/05/01
Ethics committee reference number
p/23/8/2903
Health conditions studied
1
Description of health condition studied
Renal and ureteral stones
ICD-10 code
N20.2
ICD-10 code description
Calculus of kidney with calculus of ureter
Primary outcomes
1
Description
Success rate of operation and stone crushing
Timepoint
during operation and two week later
Method of measurement
observation by nephroscope and fluroscopy during operation and with sonography and KUB two weeks later
Secondary outcomes
1
Description
Any complications of surgery(Pulmonary, vascular, visceral, neurologic and others)
Timepoint
During operation to two week later
Method of measurement
Report of patients and physician and observation with examination of patients lung,checking sensory and motors and pulse of extremities and ultrasonography
Intervention groups
1
Description
Performing tubeless percutaneous nephrolithotomy(Tubeless) under spinal anesthesia in prone position
in Group 1 (prone position) after prep of patients under spinal anesthesia( 2، 2.5 milliliter of bupivacaine and 0.5 milliliter of fentanyl) ureteral catheter 5،6 F will be inserted in ureter in the lithotomy position .Then the patient position will be changed in prone position and with fluoroscopic guidance PCNL will performed using standard methods without nephrostomy tube
Category
Treatment - Surgery
2
Description
Performing tubeless percutaneous nephrolithotomy(Tubeless) under spinal anesthesia in supine position
in Group 2 ( Supine position) after prep of patients under spinal anesthesia (2، 2.5 milliliter of bupivacaine and 0.5 milliliter of fentanyl) ureteral catheter 5،6F will be inserted in ureter in the lithotomy position .Then the patient position will be changed to supine position and with fluoroscopic guidance PCNL will performed using standard methods without nephrostomy tube.