Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000594921
Ethics application status
Approved
Date submitted
6/06/2011
Date registered
9/06/2011
Date last updated
7/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Percutaneous Nephrostomy versus Ureteroscopic Management of Sepsis Associated with Ureteral Stone Impaction: A Randomized Controlled Trial
Scientific title
the efficacy, related complications and convalescence of retrograde ureteroscopic management instead of percutaneous nephrostomy for decompression of the collecting system in cases of sepsis associated with ureteral stone impaction.
Secondary ID [1] 262330 0
Nil
Universal Trial Number (UTN)
U1111-1121-8852
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sepsis associated with ureteral stone impaction 268035 0
Condition category
Condition code
Infection 268166 268166 0 0
Other infectious diseases
Renal and Urogenital 268173 268173 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Emergency ureteroscopic lithotripsy of sepsis associated with ureteral stone impaction(Under laryngeal mask anesthesia and asymetric lithotomy position,retrograde ureteroscopic lithotripsy with lithoclast was done upon admission.The stone fragments were removed with stone grasper,the double-J catheter indwelled for internal drainage.it takes 30 minutes)
Intervention code [1] 266721 0
Treatment: Surgery
Comparator / control treatment
Emergency percutaneous nephrostomy sepsis associated with ureteral stone impaction(Under local anesthesia,prone position and sonographic guided,percutaneous nephrostomy was done upon admission it will takes 20 minutes.After the sepsis resolved,elective retrograde ureteroscopic lithotripsy with lithoclast was done.The stone fragments were removed with stone grasper,the double-J catheter indwelled for internal drainage.it takes 30 minutes
Control group
Active

Outcomes
Primary outcome [1] 266909 0
time to normalization of WBC of 10,000/mm. or less
Timepoint [1] 266909 0
WBC of 10,000/mm
Primary outcome [2] 266910 0
time to normalization of body temperature of 37.4 degrees celsiusC or less by tympanic thermometer.
Timepoint [2] 266910 0
body temperature of 37.4 degrees celsius by tympanic thermometer
Secondary outcome [1] 276606 0
analgesic consumption(oral Ketolorac 10 mg three time per day for 1 week if needed)(total doses reported by patients)
Timepoint [1] 276606 0
oral Ketolorac 10 mg three time per day for 1 week following procedure)(total doses reported by patients)
Secondary outcome [2] 276607 0
length of stay(days,data linkage to patient medical records)
Timepoint [2] 276607 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 ureteral stones and clinical signs of sepsis
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
uncorrected coagulopathy, urethral or ureteral stricture, 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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2007
Actual
1/07/2007
Date of last participant enrolment
Anticipated
31/05/2012
Actual
31/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 3615 0
Taiwan, Province Of China
State/province [1] 3615 0

Funding & Sponsors
Funding source category [1] 267205 0
Self funded/Unfunded
Name [1] 267205 0
Chung Jing Wang
Country [1] 267205 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] 266276 0
None
Name [1] 266276 0
Address [1] 266276 0
Country [1] 266276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269197 0
IRB STM
Ethics committee address [1] 269197 0
60058 No 565 Rd Ta-Ya Chia-Yi city,Taiwan ROC
St Martin De Porres Hospital
Ethics committee country [1] 269197 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 269197 0
01/01/2007
Approval date [1] 269197 0
01/04/2007
Ethics approval number [1] 269197 0
STM-IRB-2007-16

Summary
Brief summary
A randomized trial with evaluation of the efficacy, related complications and convalescence of retrograde ureteroscopic management instead of percutaneous nephrostomy for decompression of the collecting system in cases of sepsis associated with ureteral stone impaction.
Trial website
Trial related presentations / publications
not yet
Public notes

Contacts
Principal investigator
Name 32710 0
A/Prof Chung-Jing Wang
Address 32710 0
60058 No 565 Rd Ta-Ya Chia-Yi city,Taiwan ROC St Martin De Porres Hospital
Country 32710 0
Taiwan, Province Of China
Phone 32710 0
886-5-2756000-1013
Fax 32710 0
886-5-2788535
Email 32710 0
[email protected]
Contact person for public queries
Name 15957 0
A/Prof Chung Jing Wang
Address 15957 0
60058 No 565 Rd Ta-Ya Chia-Yi city,Taiwan ROC St Martin De Porres Hospital
Country 15957 0
Taiwan, Province Of China
Phone 15957 0
886-5-2756000-1013
Fax 15957 0
886-5-2788535
Email 15957 0
[email protected]
Contact person for scientific queries
Name 6885 0
A/Prof Chung Jing Wang
Address 6885 0
60058 No 565 Rd Ta-Ya Chia-Yi city,Taiwan ROC St Martin De Porres Hospital
Country 6885 0
Taiwan, Province Of China
Phone 6885 0
886-5-2756000-1013
Fax 6885 0
886-5-2788535
Email 6885 0
[email protected]

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.