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

ISRCTN	ISRCTN23480116
DOI	https://doi.org/10.1186/ISRCTN23480116
Secondary identifying numbers	N0050149623

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 05/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

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

Dr Andy Lowe
Scientific

Department of Clinical Radiology
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Phone	+44 (0)1274 364492
Email	andylowe@doctors.org.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Computed tomography (CT)-guided intervention with and without fluoroscopic control: what are the benefits for the patient and the doctor?
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	28/05/2004
Completion date	28/11/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	50
Key inclusion criteria	All adult in-patients and out-patients attending for CT guided biopsies and drainages
Key exclusion criteria	1. Acute emergency cases 2. Inability to give informed consent 3. Unconscious patients
Date of first enrolment	28/05/2004
Date of final enrolment	28/11/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Bradford Royal Infirmary

Bradford
BD9 6RJ
United Kingdom

Sponsor information

Department of Health
Government

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

Bradford Teaching Hospitals NHS Foundation Trust (UK)

No information available

Own account funding (UK)

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

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