Evaluation of the Performance of Two Neutral Oral Contrast Agents in CT Enterography

Study Overview
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Brief Summary
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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. There are several shortcomings of commonly used isotonic mannitol as an oral contrast agent, such as incident adverse reactions and gases in the gut. However, polyethylene glycol can avoid these drawbacks with a good performance in some pilot experiments.

Official Title
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Evaluation of the Performance of Two Neutral Oral Contrast Agents in CT Enterography (CTE)

Conditions
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CTE

Intervention / Treatment
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* Drug: polyethylene glycol
* Drug: mannitol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged from 18 to 75 patients undergoing CT enterography Exclusion Criteria: patients with a history of colorectal surgery patients with severe colonic stricture or obstructing tumor patients with significant gastroparesis or gastric outlet obstruction 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 severe inflammatory bowel disease or megacolon patients with documented allergy to intravascular contrast agent patients with dehydration patients with pregnancy or lactation patients hemodynamically unstable patients with dysphagia patients with severe constipation. 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to group A or B. Participants of group A are given isotonic mannitol as oral contrast agent, while participants of group B are given isotonic polyethylene glycol as oral contrast agent.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mannitol<br>Participants are given a minimum of 1500 mL of a preparation of mannitol as oral contrast agent over an hour prior to the examination. | Drug: mannitol<br>* Active comparator group was given mannitol as oral contrast agent.<br>|
| Experimental: polyethylene glycol<br>Participants are given a minimum of 1500 mL of a preparation of polyethylene glycol as oral contrast agent over an hour prior to the examination. | Drug: polyethylene glycol<br>* Experimental group was given polyethylene glycol as oral contrast agent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of two neutral oral contrast agents in CT enterography. | The assessment system includes six 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 ≥2 cm are evaluated and recorded as '0-25%', '26-50%', '51-75%' and '76-100%'. The wall visibility and visualization of the small-bowel mucosal are scored on a scale ranging from 1 to 4, in which a higher score represents a better outcome. Overall quality is assessed subjectively by the radiologist and scored on a scale ranging from 1 to 4, in which a higher score represents a better outcome. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects of the two oral contrast agents. | The degree of nausea, emesis, diarrhea, abdominal distension and cramp following ingestion are scored on a scale ranging from 0 to 10, in which a higher score represents a higher level of these targets. | 12 months | 
| The flavor, volume and participants' willing for the second use of the two oral contrast agents in CT enterography. | The flavor, volume and participants' willing for the second use are scored on a scale ranging from 0 to 10, in which a higher score represents a better outcome. | 12 months | 
| Dizziness and debilitation of patients. | The presence of dizziness and debilitation are recorded as 'yes' or 'no'. | 12 months | 
| Temperature of patients. | The temperature of patients are recorded in degree centigrade. | 12 months | 
| Blood pressure of patients. | The blood pressure of patients are recorded in millimeter of mercury. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT enterography, oral contrast agent