Computed tomography (CT)-guided intervention with and without fluoroscopic control: what are the benefits for the patient and the doctor?
ISRCTN | ISRCTN23480116 |
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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
Scientific
Department of Clinical Radiology
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Phone | +44 (0)1274 364492 |
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andylowe@doctors.org.uk |
Study information
Study design | Randomised controlled trial |
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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 |
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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
BD9 6RJ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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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 | |
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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.