CTE
Conditions
Brief summary
Small bowel distension is mandatory for the assessment of the bowel wall in CT enterography, but some patients were sufferring inadequate small bowel distension. So, it is important to prescribe personalized regimen according to patient's personal characteristics.
Detailed description
CT enterography has become an important tool in the evaluation of small bowel diseases, especially in patients with inflammatory bowel diseases. Small bowel distension is mandatory for the assessment of the bowel wall. So, it is important to find clinical risk factors for inadequate small bowel distension and prescribe personalized regimen according to patient's personal characteristics to reduce patient acceptance.
Interventions
DRUGdifferent volume of 2.5% mannitol
different volume of 2.5% mannitol based on BMI was used in active comparator group
DRUG1500ml of 2.5% mannitol
1500ml of 2.5% mannitol was used in experimental group
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients undergoing CT enterography
Exclusion criteria
* patients with a history of GI surgery * patients with known or suspected bowel obstruction or perforation * patients with severe chronic renal failure (creatinine clearance\<30 ml/min) * patients with uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg) * patients with acute upper GI bleeding * patients with severe inflammatory bowel disease or megacolon * patients with documented allergy to intravascular contrast agent * patients with pregnancy or lactation * patients hemodynamically unstable * patients unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical risk factors for inadequate small bowel distention | 2 month | Number of clinical risk factors for inadequate small bowel distention |
| Adequate small bowel distention | 4 month | The assessment system includes four parts 1. Whether the contrast reached the caecum is evaluate and recorded as yes or no 2. The overall presence of inhomogeneous contrast is evaluated and recorded as yes or no 3. The maximum dimension of a single loop in each quadrant was recorded. 4. The scale of loops of small bowel distended are evaluated and recorded as 0%-25%,26%-50%,51%-75%,75%-100% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects | 4 month | Side effects in 2 groups The degree of nausea, emesis, diarrhea, abdominal distension and cramp following ingestion are scored on a scale ranging from 0 to 4, in which a higher score represents a higher level of these targets. |
Countries
China
Contacts
Primary ContactYanqing Li, PhD, MD
Outcome results
None listed