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.

ISRCTN ISRCTN28323869
DOI https://doi.org/10.1186/ISRCTN28323869
Secondary identifying numbers N0236151199
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
14/09/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Khurshid Ridwan Ghani
Scientific

Urology Research Department
1st Floor, Ingleby House
St Georges Hospital
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom

Phone +44 (0)20 8725 0271
Email Khurshid.ghani@stgeorges.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Scientific title
Study objectivesTo 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.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Renal
InterventionResearch 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.
Intervention typeProcedure/Surgery
Primary outcome measureReduced time to retrieve target calyceal calculus compared to control.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/05/2003
Completion date30/09/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants20
Key inclusion criteriaNot provided at time of registration
Key exclusion criteria1. Patients > 30 stone
2. Pregnant women
3. Patients with severe learning difficulties
4. Patients with acute mental illness
Date of first enrolment01/05/2003
Date of final enrolment30/09/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Urology Research Department
London
SW17 0QT
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

St George's Healthcare NHS Trust (UK) NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2009 Yes No