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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleComputed tomography (CT)-guided intervention with and without fluoroscopic control: what are the benefits for the patient and the doctor?
Study objectivesDoes 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) studiedComputed tomography-guided interventions
InterventionAll 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 typeProcedure/Surgery
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date28/05/2004
Completion date28/11/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants50
Key inclusion criteriaAll adult in-patients and out-patients attending for CT guided biopsies and drainages
Key exclusion criteria1. Acute emergency cases
2. Inability to give informed consent
3. Unconscious patients
Date of first enrolment28/05/2004
Date of final enrolment28/11/2004

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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