| Source of record | UK Trials |
| ISRCTN | ISRCTN98984328 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0280190231 |
| Public title | The effect of needle thickness on the diagnosis of prostate cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cancer: Prostate |
| Study hypothesis | 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 75-100 consecutive men undergoing TRUS prostate biopsies for investigation into a raised PSA level &/or an abnormal digital rectal examination (DRE). |
| Participants - exclusion criteria | No exclusion criteria |
| Patient information material |
|
| Anticipated start date | 01/12/2006 |
| Anticipated end date | 01/12/2007 |
| Status of trial | Completed |
| Target number of participants | 100 |
| Interventions | Double blind binary randomization to either large needle TRUS biopsy or small needle TRUS biopsy. |
| Primary outcome measure(s) | 1. Pre-op erectile dysfunction questionnaire
2. Post-op pain evaluation
3. Complication & ED questionnaire
4. Prostate histopathology |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Wirral Hospitals NHS Trust
|
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr Rahul Mistry |
| Contact details | Urology Dept, Ward M2
Clatterbridge Hospital
Clatterbridge Road
Bebington
Wirral
United Kingdom
CH63 4JY |
| Contact telephone | +44 07967339014 |
| Contact fax | +44 0151 6047143 |
| Contact email | rahulmistry1@hotmail.com |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN98984328 |
| Date last extracted from ISRCTN register | 17/04/2008 |
