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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03567421




Registration number
NCT03567421
Ethics application status
Date submitted
26/04/2018
Date registered
25/06/2018

Titles & IDs
Public title
Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes
Scientific title
Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes
Secondary ID [1] 0 0
uCARE 2018-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stone;Renal 0 0
Stone, Kidney 0 0
Stone Ureter 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Renal and Urogenital 0 0 0 0
Kidney disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of patients receiving an internal drain following treatment for urinary stones by ureteroscopy
Assessment method [1] 0 0
This number will be reported as a % of the total patients enrolled.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Number of patients requiring secondary interventions [N]
Assessment method [1] 0 0
Post-operative secondary interventions include JJ placement, ureter splint placement, nephrostomy tube placement, reURS, clot removal, pharmacological intervention, or other.
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Number of patients requiring pain medication at discharge [N]
Assessment method [2] 0 0
Pain defined as that requiring additional therapy or pain medication, or prolonged hospital stay due to pain.
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Duration of the actual internal drain indwelling time [days]
Assessment method [3] 0 0
This number is auto-calculated based from the date of surgery, and date of stent removal or post-operative visit (if no stent was used)
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Duration of the internal drain indwelling time as indicated by the surgeon [days]
Assessment method [4] 0 0
Calculated as number of days.
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
% of patients who required anaesthesia for stent removal [Yes/No]
Assessment method [5] 0 0
This intraoperative information will be provided by surgeon to indicate whether anesthesia was required during stent removal. Data to be reported as % of total patients.
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Incidence of use of flexible instruments for stent removal following ureteroscopy.
Assessment method [6] 0 0
As indicated by treating surgeon \[Yes/No response\].
Timepoint [6] 0 0
6 months

Eligibility
Key inclusion criteria
* Patient >18 years old
* Patient is a candidate for ureteroscopic treatment of a ureter or renal stone by semi-rigid and/or flexible ureteroscopy
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Patient <18 years old

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2019
Sample size
Target
Accrual to date
Final
2348
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Minnesota
Country [2] 0 0
China
State/province [2] 0 0
Guangdong
Country [3] 0 0
China
State/province [3] 0 0
Guangzhou
Country [4] 0 0
China
State/province [4] 0 0
Ningbo
Country [5] 0 0
China
State/province [5] 0 0
Shanghai
Country [6] 0 0
China
State/province [6] 0 0
Wuhan
Country [7] 0 0
Greece
State/province [7] 0 0
Athens
Country [8] 0 0
Greece
State/province [8] 0 0
Heraklion
Country [9] 0 0
Greece
State/province [9] 0 0
Larissa
Country [10] 0 0
Greece
State/province [10] 0 0
Thessaloníki
Country [11] 0 0
India
State/province [11] 0 0
Rajasthan
Country [12] 0 0
India
State/province [12] 0 0
Pune
Country [13] 0 0
Indonesia
State/province [13] 0 0
Bandung
Country [14] 0 0
Indonesia
State/province [14] 0 0
Denpasar
Country [15] 0 0
Indonesia
State/province [15] 0 0
Jakarta
Country [16] 0 0
Indonesia
State/province [16] 0 0
Malang
Country [17] 0 0
Indonesia
State/province [17] 0 0
Surabaya
Country [18] 0 0
Indonesia
State/province [18] 0 0
Yogyakarta
Country [19] 0 0
Iran, Islamic Republic of
State/province [19] 0 0
Hamadan
Country [20] 0 0
Iraq
State/province [20] 0 0
Basra
Country [21] 0 0
Kenya
State/province [21] 0 0
Mombasa
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seoul
Country [23] 0 0
Malaysia
State/province [23] 0 0
Batu Caves
Country [24] 0 0
Malaysia
State/province [24] 0 0
Kajang
Country [25] 0 0
Malaysia
State/province [25] 0 0
Kuala Lumpur
Country [26] 0 0
Malaysia
State/province [26] 0 0
Kuching
Country [27] 0 0
Romania
State/province [27] 0 0
Bucharest
Country [28] 0 0
Saudi Arabia
State/province [28] 0 0
Jeddah
Country [29] 0 0
Saudi Arabia
State/province [29] 0 0
Riyadh
Country [30] 0 0
South Africa
State/province [30] 0 0
Ga-Rankuwa
Country [31] 0 0
Taiwan
State/province [31] 0 0
Kaohsiung
Country [32] 0 0
Taiwan
State/province [32] 0 0
New Taipei City
Country [33] 0 0
Taiwan
State/province [33] 0 0
Taipei
Country [34] 0 0
Turkey
State/province [34] 0 0
Adana
Country [35] 0 0
Turkey
State/province [35] 0 0
Ankara
Country [36] 0 0
Turkey
State/province [36] 0 0
Istanbul
Country [37] 0 0
Turkey
State/province [37] 0 0
Izmir
Country [38] 0 0
Turkey
State/province [38] 0 0
Konya
Country [39] 0 0
Turkey
State/province [39] 0 0
Zonguldak

Funding & Sponsors
Primary sponsor type
Other
Name
Société Internationale d'Urologie
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Joyce Baard, MD
Address 0 0
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03567421