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

Urology Dept, Ward M2
Clatterbridge Hospital
Clatterbridge Road
Bebington
Wirral
CH63 4JY
United Kingdom

Phone +44 (0)7967339014
Email rahulmistry1@hotmail.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe effect of needle thickness on the diagnosis of prostate cancer
Study objectives1. 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) studiedCancer: Prostate
InterventionDouble blind binary randomization to either large needle TRUS biopsy or small needle TRUS biopsy.
Intervention typeOther
Primary outcome measure1. Pre-op erectile dysfunction questionnaire
2. Post-op pain evaluation
3. Complication & ED questionnaire
4. Prostate histopathology
Secondary outcome measuresNot provided at time of registration
Overall study start date01/12/2006
Completion date01/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants100
Key inclusion criteria75-100 consecutive men undergoing TRUS prostate biopsies for investigation into a raised PSA level &/or an abnormal digital rectal examination (DRE)
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/12/2006
Date of final enrolment01/12/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Clatterbridge Hospital
Wirral
CH63 4JY
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, 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

Wirral Hospitals NHS Trust

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

Editorial Notes

12/10/2017: No publications found, verifying study status with principal investigator.