Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001278820
Ethics application status
Approved
Date submitted
4/12/2012
Date registered
11/12/2012
Date last updated
27/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
percutaneous nephrostomy for purely ultrasound guided percutaneous nephrolithotomy
Scientific title
percutaneous nephrostomy as a training means for novice urologists to purely ultrasound guided percutaneous nephrolithotomy-success rate of calyx puncture and tract dilation compared with those with initial experience of purely ultrasound guided percutaneous nephrolithotomy
Secondary ID [1] 281645 0
Nil
Universal Trial Number (UTN)
U1111-1136-9435
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
kidney stone 287903 0
Condition category
Condition code
Renal and Urogenital 288282 288282 0 0
Kidney disease
Public Health 288310 288310 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intervention: as a training means, novice urologists will undertake 10 cases of percutaneous nephrostomy during six months before doing percutaneous nephrolithotomy independently. All the manipulation was supervised by a senior urologist who are completent in percutaneous nephrostomy and percutaneous nephrolithotomy. And the urologists' independent percutaneous nephrolithotomy is part of this trial.
Intervention code [1] 286155 0
Other interventions
Comparator / control treatment
the urologists in control group have no training with percutaneous nephrostomy but during the past six months have performed 10 cases of purely ultrasound guided percutaneous nephrolithotomy which means that percutaneous nephrolithotomy is performed under the sole guidance of ultrasound including puncture and tract dilation.
Control group
Active

Outcomes
Primary outcome [1] 288456 0
success rate of calyx puncture was assessed by the number of successful puncture with needle into the calyx/the total number of puncture. All the data is from the medical records.
Timepoint [1] 288456 0
immediately after surgery
Primary outcome [2] 288457 0
success rate of tract dilation was assessed by the number of successful tract dilation/the total number of tract dilation. All the data is from the medical records.
Timepoint [2] 288457 0
immediately after surgery
Secondary outcome [1] 300196 0
stone-free rate was assessed by the number of patients with stone-free/ the total number of patients undergoing surgery. All the data is from the medical records.
Timepoint [1] 300196 0
one-monthe after surgery
Secondary outcome [2] 300197 0
operation time from the beginning of the puncture to the end of surgery
Timepoint [2] 300197 0
immediately at surgery
Secondary outcome [3] 300198 0
hospitalization days was the time from admission to discharge. All the data is from the medical records.
Timepoint [3] 300198 0
immediately after surgery

Eligibility
Key inclusion criteria
patients with pelvic stones
Minimum age
20 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
prior open surgery; obese

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
opaque, sealed, and sequentially numbered envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
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
Withdrawn
Reason for early stopping/withdrawal
Safety concerns
Date of first participant enrolment
Anticipated
1/01/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 4674 0
China
State/province [1] 4674 0
shanghai

Funding & Sponsors
Funding source category [1] 286429 0
Government body
Name [1] 286429 0
funds for GCP platform of urogenical tumor
Country [1] 286429 0
China
Primary sponsor type
Individual
Name
sun yinghao
Address
changhai road 168#, shanghai
Country
China
Secondary sponsor category [1] 285213 0
Individual
Name [1] 285213 0
zhou tie
Address [1] 285213 0
changhai road 168#, shanghai
Country [1] 285213 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288508 0
ethics committee of changhai hospital
Ethics committee address [1] 288508 0
changhai road 168#, shanghai
Ethics committee country [1] 288508 0
China
Date submitted for ethics approval [1] 288508 0
15/12/2012
Approval date [1] 288508 0
25/12/2012
Ethics approval number [1] 288508 0
CHEC2012-103

Summary
Brief summary
To overcome the learning curve of purely ultrasound guided PCNL, we hypothesize the possibility of percutaneous nephrostomy as a training means for purely ultrasound guided PCNL.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34937 0
Prof Sun Yinghao
Address 34937 0
changhai road 168#, shanghai
Country 34937 0
China
Phone 34937 0
+8602135030006
Fax 34937 0
Email 34937 0
[email protected]
Contact person for public queries
Name 18184 0
Zhou tie
Address 18184 0
changhai road 168#, shanghai
Country 18184 0
China
Phone 18184 0
+8602135030006
Fax 18184 0
+8602135030006
Email 18184 0
[email protected]
Contact person for scientific queries
Name 9112 0
Zhou tie
Address 9112 0
changhai road 168#, shanghai
Country 9112 0
China
Phone 9112 0
+8602135030006
Fax 9112 0
+8602135030006
Email 9112 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.