Individualized Volume of Oral Contrast Agent in CT Enterography

Study Overview
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Brief Summary
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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
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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.

Official Title
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Individualized Volume of Oral Contrast Agent Based on the Clinical Risk Factor in CT Enterography: a Randomized Controlled Trial

Conditions
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CTE

Intervention / Treatment
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* Drug: 1500ml of 2.5% mannitol
* Drug: different volume of 2.5% mannitol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Individualized group<br>Participants are given different volume of a preparation of mannitol based on BMI as oral contrast agent over an hour prior to the examination. | Drug: 1500ml of 2.5% mannitol<br>* 1500ml of 2.5% mannitol was used in experimental group<br>Drug: different volume of 2.5% mannitol<br>* different volume of 2.5% mannitol based on BMI was used in active comparator group<br>|
| Experimental: conventional group<br>Participants are given 1500ml of a preparation of mannitol as oral contrast agent over an hour prior to the examination. | Drug: 1500ml of 2.5% mannitol<br>* 1500ml of 2.5% mannitol was used in experimental group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical risk factors for inadequate small bowel distention | Number of clinical risk factors for inadequate small bowel distention | 2 month | 
| Adequate small bowel distention | The assessment system includes four parts Whether the contrast reached the caecum is evaluate and recorded as yes or no The overall presence of inhomogeneous contrast is evaluated and recorded as yes or no The maximum dimension of a single loop in each quadrant was recorded. The scale of loops of small bowel distended are evaluated and recorded as 0%-25%,26%-50%,51%-75%,75%-100% | 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | 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. | 4 month |