Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
05/07/2016
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 Andy Lowe

ORCID ID

Contact details

Department of Clinical Radiology
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 364492
andylowe@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0050149623

Study information

Scientific title

Computed tomography (CT)-guided intervention with and without fluoroscopic control: what are the benefits for the patient and the doctor?

Acronym

Study hypothesis

Does the introduction of fluoroscopy in computed tomography (CT)-guided intervention decrease procedure time and dose exposure and does it make the procedure technically easier and improve outcome?

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

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Computed tomography-guided interventions

Intervention

All patients attending for CT-guided interventions (biopsies and drainages) are invited to take part. Patients randomised to have procedure in conventional manner with CT guidance (controls) or with additional fluoroscopy. Time taken to have procedure, effective dose to patient, operator and assistant, patient comfort and acceptability, number of passes/complications and degree of technical success measured.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

1. Dose product to patient
2. Effective dose to patient
3. Effective dose to doctor and nurse/assistant
4. Hand dose to doctor
5. Screening time
All measured using electronic dose meters

6. Comfort and acceptability Questionnaire
7. BIOPSY - Number of passes, complications and diagnostic specimens
8. DRAINAGES - Number of passes, Complications and Technical success

Secondary outcome measures

No secondary outcome measures

Overall trial start date

28/05/2004

Overall trial end date

28/11/2004

Reason abandoned

Eligibility

Participant inclusion criteria

All adult in-patients and out-patients attending for CT guided biopsies and drainages

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Acute emergency cases
2. Inability to give informed consent
3. Unconscious patients

Recruitment start date

28/05/2004

Recruitment end date

28/11/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bradford Royal Infirmary
Bradford
BD9 6RJ
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

Bradford Teaching Hospitals NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Own account funding (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

05/07/2016: No publications found, verifying study status with principal investigator.