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Trial registered on ANZCTR


Registration number
ACTRN12611000600943
Ethics application status
Approved
Date submitted
8/06/2011
Date registered
10/06/2011
Date last updated
7/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Percutaneous Nephrostomy versus Emergency Percutaneous Nephrolithotomy of Sepsis Associated with Uretero-Pelvic Junctional Stone Impaction: A Randomized Controlled Trial
Scientific title
Percutaneous nephrostomy versus emergency percutaneous nephrolithotomy of sepsis associated with uretero-pelvic stone impaction
Secondary ID [1] 262338 0
Nil
Universal Trial Number (UTN)
U1111-1121-9931
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sepsis associated with uretero-pelvic junctional stone impaction 268041 0
Condition category
Condition code
Infection 268174 268174 0 0
Other infectious diseases
Renal and Urogenital 268186 268186 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
emergency percutaneous nephrolithotomy for decompression of the collecting system in cases of sepsis associated with uretero-pelvic junctional stone impaction.(Under endotracheal anesthesia and sonographic guided,percutaneous nephrolithotomy was done to remove the impacted stone with double-J catheter indwelling for internal drainage upon admission,the whole course will take 30 minutes)
Intervention code [1] 266727 0
Treatment: Surgery
Comparator / control treatment
percutaneous nephrostomy for decompression of the collecting system in cases of sepsis associated with uretero-pelvic junctional stone impaction(Under local anesthesia and sonographic guided,percutaneous nephrostomy was done to for decompression of hydronephrosis upon admission.it will take 20 minutes. After sepsis resolved,elective percutaneous nephrolithotomy was done to remove the impacted stone with double-J catheter indwelling for internal drainage)
Control group
Active

Outcomes
Primary outcome [1] 266919 0
time to normalization of WBC of 10,000/mm. or less(check complete blood count once a day during the admission)
Timepoint [1] 266919 0
time to normalization of WBC of 10,000/mm. or less(check complete blood count once a day during the admission)
Primary outcome [2] 266920 0
time to normalization of body temperature of 37.4 degrees celsius or less by tympanic thermometer.
Timepoint [2] 266920 0
body temperature of 37.4 degrees celsius by tympanic thermometer
Secondary outcome [1] 276625 0
analgesic consumption(oral Ketolorac 10 mg three time per day for 1 week if needed,total doses recorded by medical records)
Timepoint [1] 276625 0
oral Ketolorac 10 mg three time per day 1 week post surgery
Secondary outcome [2] 276626 0
length of stay(days,data linkage to patient medical records)
Timepoint [2] 276626 0
days of admission(data linkage to patient medical records)

Eligibility
Key inclusion criteria
Adult patients presenting to the emergency room or admitted to the hospital with obstructing uretero-pelvic junctional stones and clinical signs of sepsis were asked to participate in this randomized study. The inclusion criteria included a white blood count (WBC) of 10,000 mm. or greater and or temperature 38 degrees celsius or greater.
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
uncorrected coagulopathy, urinary diversion, pregnancy, solitary kidney, and unwillingness or impossibility to commit to the study follow-up protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random numbers table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2007
Actual
1/01/2007
Date of last participant enrolment
Anticipated
31/07/2012
Actual
31/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 3619 0
Taiwan, Province Of China
State/province [1] 3619 0
Taiwan

Funding & Sponsors
Funding source category [1] 267216 0
Self funded/Unfunded
Name [1] 267216 0
Chung Jing Wang
Country [1] 267216 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Chung Jing Wang
Address
60058 No 565 Rd Ta-Ya Chia-yi city Taiwan ROC St Martin De Porres Hospital
Country
Taiwan, Province Of China
Secondary sponsor category [1] 266283 0
None
Name [1] 266283 0
Address [1] 266283 0
Country [1] 266283 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269207 0
IRB STM
Ethics committee address [1] 269207 0
Ethics committee country [1] 269207 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 269207 0
24/10/2006
Approval date [1] 269207 0
15/11/2006
Ethics approval number [1] 269207 0
STM IRB-2006-17

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32716 0
A/Prof Chung Jing Wang
Address 32716 0
60058 No 565 Rd Ta-Ya Chia-yi city Taiwan ROC St Martin De Porres Hospital
Country 32716 0
Taiwan, Province Of China
Phone 32716 0
886-5-2756000-1013
Fax 32716 0
886-5-2788535
Email 32716 0
jing@stm.org.tw
Contact person for public queries
Name 15963 0
Chung Jing Wang
Address 15963 0
60058 No 565 Rd Ta-Ya Chia-yi city Taiwan ROC St Martin De Porres Hospital
Country 15963 0
Taiwan, Province Of China
Phone 15963 0
886-5-2756000-1013
Fax 15963 0
886-5-2788535
Email 15963 0
jing@stm.org.tw
Contact person for scientific queries
Name 6891 0
Chung Jing Wang
Address 6891 0
60058 No 565 Rd Ta-Ya Chia-yi city Taiwan ROC St Martin De Porres Hospital
Country 6891 0
Taiwan, Province Of China
Phone 6891 0
886-5-2756000-1013
Fax 6891 0
886-5-2788535
Email 6891 0
jing@stm.org.tw

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.