Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
18/03/2016
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

Dr A S Lowe

ORCID ID

Contact details

Radiology
Lincoln Wing
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 243 3144
r&d@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436146667

Study information

Scientific title

Does the use of local anaesthetic make trans-rectal ultrasound guided biopsy more comfortable. To evaluate the pain experienced by the patient when having this procedure

Acronym

Study hypothesis

To assess whether the use of local anaesthetic makes trans-rectal ultrasound guided biopsy more comfortable. To evaluate the pain experienced by the patient when having this procedure.

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

Diagnostic

Patient information sheet

Condition

Surgery: Anaesthesia

Intervention

Randomised controlled trial

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2002

Overall trial end date

01/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Male patients referred for trans-rectal ultrasound guided biopsy as an outpatient to St James's

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

50

Participant exclusion criteria

1. Patients who are unable to answer the questionnaire (at the discretion of the radiographer, eg dementia, mental illness, language difficulties)
2. Patients not suitable for trans-rectal ultrasound biopsy

Recruitment start date

01/08/2002

Recruitment end date

01/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St James's University Hospital, Radiology
Lincoln Wing Beckett Street
Leeds
LS9 7TF
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

Leeds Teaching Hospitals NHS Trust (UK)

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

Publication citations

Additional files

Editorial Notes

18/03/2016: No publications found, verifying study status with principal investigator