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
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 |
|---|---|
| Khurshid.ghani@stgeorges.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Renal |
| Intervention | 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. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Reduced time to retrieve target calyceal calculus compared to control. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/2003 |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 20 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | 1. Patients > 30 stone 2. Pregnant women 3. Patients with severe learning difficulties 4. Patients with acute mental illness |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 30/09/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Urology Research Department
London
SW17 0QT
United Kingdom
SW17 0QT
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
