Subjects referred for abdominal or thoracoabdominal CT-examination will be randomised to either the three contrast agents Lumentin® 44, Omnipaque® or Movprep. The difference in contrast density, as observed in the CT-examination, between lumen and wall (mucosal lining) will be compared by the three contrast agents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
45
Contrast agent
Contrast agent
Contrast agent
Department of medical imaging and function
Malmö, Sweden
Relative Mean Difference in Contrast Density
difference in contrast density between lumen and wall (mucosal lining)
Time frame: Day 1
Bowel Filling Properties, Extension
The bowel filling agent was distributed along the length of small bowel, i.e. the extension. The filling of each of the 5 selected sub-segments of the small bowel in terms of extension was examined on the CT-scan by 2 investigators, independently of each other, and graded using Likert scales between 1 and 9. Extension scale: 1. No sign of contrast agent 2. Trace of contrast agent filling 3. Segment filled to ca. 25% 4. Segment filled to \>25% but \<50% 5. Filled to segment filled to 50% 6. Segment filled \> 50% but \<75% 7. Segment filled to ca. 75% 8. Segment filled to \>75% but \<100% 9. Segment filled to 100% The evaluation was made by 2 independent radiology experts. The Extension score is the sum of the grades in each sub-segment from both evaluations and hence range from 10 to 90.
Time frame: Day 1
Bowel Filling Properties, Distension
The bowel filling agent caused a local widening of the bowel loop, distension. The filling of each of the 5 selected sub-segments of the small bowel in terms of distension was examined on the CT-scan by both the 2 investigators independently of each other, and graded using Likert scales between 1 and 9. Distension scale: 1. No identifiable contrast agent 2. A minimal amount of contrast agent is identified 3. Small amount of contrast agent, insufficient for placing a ROI of 6 mm 4. Amount of contrast agent just allowing for a ROI of 6 mm 5. Medium filled bowel loop 6. Slightly better than grade 5 7. Good filling 8. Optimal filling 9. Excellent or almost over distended The evaluation was made by 2 independent radiology experts. The Distension score is the sum of the grades in each sub-segment from both evaluations and hence range from 10 to 90.
Time frame: Day 1
Diagnostic Ability When Examining Abdominal CT
Diagnostic ability when examining Abd-CT was assessed on the CT-scan by the 2 investigators independently of each other. The following features were assessed: * Small bowel appearance * Parenchymal organs, i.e. Pancreas, ovaries, urinary bladder * Mesenterium and omentum using a Likert scales of 1-9 ranging, where: 1.Impossible to observe details 5\. Medium 9\. Excellent resolution The evaluation was made by 2 independent radiology experts. The Diagnostic ability score is the sum of the scores of each feature from both evaluations and hence range from 6 to 54.
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Time frame: Day 1
Degradation of Contrast Agent (Lumentin® 44)
Degradation of Lumentin 44 was founded on the 2 characteristics; coalescence and syneresis or drainage. Coalescence: 0\. No bubbles visually detectable at the CT-scan 1\. Bubbles visually detectable at the CT-scan Syneresis or drainage: 0\. No syneresis or drainage, i.e. separation of air and liquid phases, observed 1\. Syneresis or drainage observed Signs of degradation were assessed on the CT-scan, by both Investigator and Sub-Investigator, independently of each other, in each of the 5 selected sub-segments of the small bowel. The degradation of contrast agents score is the sum of the scores in each sub-segment and range from 0 to 10.
Time frame: Day 1
Subjects' Assessment of Taste of the Contrast Agent
The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive
Time frame: Day 1
Subjects' Assessment of Smell of the Contrast Agent
The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive
Time frame: Day 1
Subjects' Assessment of Consistency of the Contrast Agent
The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive
Time frame: Day 1
Subjects' Assessment of Ability to Swallow the Contrast Agent
The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive
Time frame: Day 1
Subjects' Assessment of Fullness After Drinking the Contrast Agent
The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive
Time frame: Day 1