Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-01-01
2020-01-31
Brief Summary
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Detailed Description
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There are two options for urgent decompression of an obstructed collecting system:
1. Image-guided percutaneous nephrostomy tube placement
2. Cystoscopic retrograde placement of a ureteric stent
This strategy allows drainage of infected urine and penetration of antibiotics to the affected renal unit. Definitive stone manipulation should be delayed until the infection is cleared following an appropriate course of antimicrobial therapy.
Both the European Association of Urology (EAU) and the American Urological Association (AUA) provide guidelines for management of an obstructed kidney. Both organisations provide evidence-based statements of the highest recommendation that urgent decompression of the kidney is mandated in the setting of sepsis. However, neither organisation recommend one decompression modality over the other. There is a lack of high quality up-to-date evidence to support a consensus view that one method of decompression is superior to the other.
This study aims to determine the most effective method of renal decompression in cases of obstruction and sepsis associated with ureteric calculi.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PCN
Percutaneous nephrostomy
Percutaneous nephrostomy
Percutaneous nephrostomy tube insertion under radiological guidance
JJ Stent
Retrograde ureteric JJ stent
Retrograde ureteric JJ stent
Retrograde ureteric JJ stent insertion using cystoscopy
Interventions
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Percutaneous nephrostomy
Percutaneous nephrostomy tube insertion under radiological guidance
Retrograde ureteric JJ stent
Retrograde ureteric JJ stent insertion using cystoscopy
Eligibility Criteria
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Inclusion Criteria
* White cell count \>12,000mm3 and/or temperature \>38C
Exclusion Criteria
* Urethral or ureteric stricture disease
* Urinary diversion
* Pregnancy
18 Years
ALL
No
Sponsors
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The Adelaide and Meath Hospital, incorporating The National Children's Hospital
OTHER
Responsible Party
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Rustom P Manecksha, MD, FRCS (Urol.)
Consultant Urologist
Locations
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The Adelaide and Meath Hospital, incorporating The National Children's Hospital
Tallaght, Dublin, Ireland
St. James's Hospital
Dublin, , Ireland
Countries
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Other Identifiers
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2016-004022-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AMNCH-GU-2016-1
Identifier Type: -
Identifier Source: org_study_id
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