Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
14/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Khurshid Ridwan Ghani

ORCID ID

Contact details

Urology Research Department
1st Floor
Ingleby House
St Georges Hospital
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
+44 (0)20 8725 0271
Khurshid.ghani@stgeorges.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0236151199

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Reduced time to retrieve target calyceal calculus compared to control.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2003

Overall trial end date

30/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

1. Patients > 30 stone
2. Pregnant women
3. Patients with severe learning difficulties
4. Patients with acute mental illness

Recruitment start date

01/05/2003

Recruitment end date

30/09/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Urology Research Department
London
SW17 0QT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19142644

Publication citations

  1. Results

    Patel U, Walkden RM, Ghani KR, Anson K, Three-dimensional CT pyelography for planning of percutaneous nephrostolithotomy: accuracy of stone measurement, stone depiction and pelvicalyceal reconstruction., Eur Radiol, 2009, 19, 5, 1280-1288, doi: 10.1007/s00330-008-1261-x.

Additional files

Editorial Notes