The aim of this study is to compare the image quality, diagnostic confidence and patient discomfort when using either positive (50 ml Télébrix Gastro + 950 ml water ) or negative 1000 ml water only in outpatients undergoing a contrast-enhanced…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Hepatic and hepatobiliary disorders
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary parameters: quality of the scans and the diagnostic confidence by the
radiologist.
Secondary outcome
Secondary parameters: patients discomfort and radiation exposure.
Background summary
Although CT protocols vary by institution, equipment, setting and clinical
question, the default protocol in our practice for outpatient contrast-enhanced
abdominal CT scans includes both oral contrast including Télébrix Gastro (so
called positive oral contrast) and IV contrast administration. The
justification for oral contrast for emergency department patients has been
questioned and extensively studied leading to withholding any oral contrast.
The advantages of withholding oral contrast in the emergency department may be
translated to routine intravenously enhanced CT of the abdomen in the
outpatient setting. However there are no data on withholding of oral contrast
in this patient population. In different studies, however the positive oral
contrast has been replaced by water only, so called **negative oral contrast*.
The routine use of positive contrast in the outpatient setting has multiple
direct and indirect effects, including increased cost, decreased practice
efficiency, patient inconvenience and discomfort and higher radiation exposure.
Study objective
The aim of this study is to compare the image quality, diagnostic confidence
and patient discomfort when using either positive (50 ml Télébrix Gastro + 950
ml water ) or negative 1000 ml water only in outpatients undergoing a
contrast-enhanced abdominal CT scans.
Study design
A single-centre study including 200 patients (100 in each arm). Patients will
be randomised by a four block randomisation procedure.
Patient will receive either negative oral contrast (1000 ml water) or positive
oral contrast (50 ml Télébrix Gastro + 950 ml water).
Study burden and risks
BURDEN:
1) Patients will be allocated to one of the arms.
2) Patients will be asked to complete a questionnaire.
RISKS ASSOCIATED WITH PARTICIPATION
We do not expect any risk associated with oral water administration.
LONG AND SHORT TERM BENEFITS
There are no benefits for participants. In the future replacing positive
contrast by negative contrast agent, will lead to cost savings (direct and
indirect), better patients acceptance and presumable lower radiation exposure.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Patients scheduled to undergo an abdominal CT with oral contrast at the department of Radiology;
Outpatients;
> 18 years.
Exclusion criteria
Patients undergoing CT for other research purpose;
Patients who are not willing to participate;
Not able to understand and/or give written informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63168.018.17 |