The effect of needle thickness on the diagnosis of prostate cancer
ISRCTN | ISRCTN98984328 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN98984328 |
Secondary identifying numbers | N0280190231 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 12/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Rahul Mistry
Scientific
Scientific
Urology Dept, Ward M2
Clatterbridge Hospital
Clatterbridge Road
Bebington
Wirral
CH63 4JY
United Kingdom
Phone | +44 (0)7967339014 |
---|---|
rahulmistry1@hotmail.com |
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Diagnostic |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | The effect of needle thickness on the diagnosis of prostate cancer |
Study objectives | 1. To determine if using smaller needles to biopsy the prostate provides tissue that is equally accurate for histopathological examination. 2. To analyse the post-operative pain perception following local anaesthetic infiltration or sedation prostrate biopsies. 3. To determine if there are any post-operative complications or erectile dysfunction following prostrate biopsies. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Cancer: Prostate |
Intervention | Double blind binary randomization to either large needle TRUS biopsy or small needle TRUS biopsy. |
Intervention type | Other |
Primary outcome measure | 1. Pre-op erectile dysfunction questionnaire 2. Post-op pain evaluation 3. Complication & ED questionnaire 4. Prostate histopathology |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/12/2006 |
Completion date | 01/12/2007 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Male |
Target number of participants | 100 |
Key inclusion criteria | 75-100 consecutive men undergoing TRUS prostate biopsies for investigation into a raised PSA level &/or an abnormal digital rectal examination (DRE) |
Key exclusion criteria | Does not meet inclusion criteria |
Date of first enrolment | 01/12/2006 |
Date of final enrolment | 01/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clatterbridge Hospital
Wirral
CH63 4JY
United Kingdom
CH63 4JY
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, 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
Wirral Hospitals NHS Trust
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 |
Editorial Notes
12/10/2017: No publications found, verifying study status with principal investigator.