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ISRCTN
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ISRCTN28323869
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled study to evaluate the pelvi-calyceal anatomy of the kidney using three-dimensional multi-detector row CT (MDCT) imaging in patients before undergoing percutaneous renal intervention.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0236151199
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Study hypothesis
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To evaluate the use of 3-dimensional multi-detector row computerised tomography (3D MDCT) in the treatment of renal pelvi-calyceal disease. The primary objective is to determine whether 3D MDCT is a valid and reliable pre-operative planning tool for endourological and percutaneous access to the collecting system of the kidney. The secondary objective is to assess whether pre-operative 'virtual endoscopy' performed using the 3D data, aids endourological removal of the calyceal stone.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Surgery: Renal
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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1. Patients > 30 stone
2. Pregnant women
3. Patients with severe learning difficulties
4. Patients with acute mental illness
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Anticipated start date
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01/05/2003
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Anticipated end date
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30/09/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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20
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Interventions
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Research investigating the application of 3D imaging in endourolgy is in its infancy. To gain percutaneous access to the kidney and perform subsequent renoscopy in order to remove renal stones for example, the urologist and uroradiologist must have excellent 3D spatial awareness. Currently patients have 2D images taken pre-operatively. Interventionalists use this data to mentally reconstruct a 3D image of the internal calyceal anatomy. Understanding the anatomy is key to a successful intervention. What would be of value is a reliable and valid imaging tool that is able to reconstruct in 3D the calyceal anatomy pre-operatively, and aid endourolgical intervention. Normally patients with complex renal stones requiring surgery have IVU's and CT's taken preoperatively at SGH. We aim to obtain out-patient multi-slice CT scans on patients who fit our inclusion criteria, and who will be undergoing percutaneous intervention in the future. The CT scans will be done as an outpatient investigation at the CT scan department of Princess Grace Hospital (the cost of which will be met by PGH administration). 3D CT will allow reconstruction of the fine ramifications of intracalyceal anatomy. It is our hypothesis that with this data, 3D volume reconstruction will help in pre-operative planning, it will allow us to determine best route of access as well as allowing virtual endoscopy to be done prior to the procedure. It is hoped this will have beneficial outcomes in terms of operative ability and morbidity.
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Primary outcome measure(s)
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Reduced time to retrieve target calyceal calculus compared to control.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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St George's Healthcare NHS Trust (UK) NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Mr
Khurshid Ridwan
Ghani
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Address
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Urology Research Department
1st Floor, Ingleby House
St Georges Hospital
Blackshaw Road
Tooting
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City/town
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London
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Zip/Postcode
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SW17 0QT
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Country
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United Kingdom
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Tel
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+44 (0)20 8725 0271
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Fax
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+44 (0)20 8725 2872
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Email
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Khurshid.ghani@stgeorges.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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23/02/2010
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Date ISRCTN assigned
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30/09/2005
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