Evaluation of the Performance of Two Neutral Oral Contrast Agents in CT Enterography
- Registration Number
- NCT03495804
- Lead Sponsor
- Shandong University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- patients aged from 18 to 75
- patients undergoing CT enterography
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mannitol mannitol Participants are given a minimum of 1500 mL of a preparation of mannitol as oral contrast agent over an hour prior to the examination. polyethylene glycol polyethylene glycol 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.
- Primary Outcome Measures
Name Time Method Performance of two neutral oral contrast agents in CT enterography. 12 months The assessment system includes six 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 ≥2 cm are evaluated and recorded as '0-25%', '26-50%', '51-75%' and '76-100%'.
5. 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.
6. 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.
- Secondary Outcome Measures
Name Time Method Side effects of the two oral contrast agents. 12 months 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.
Blood pressure of patients. 12 months The blood pressure of patients are recorded in millimeter of mercury.
The flavor, volume and participants' willing for the second use of the two oral contrast agents in CT enterography. 12 months 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.
Temperature of patients. 12 months The temperature of patients are recorded in degree centigrade.
Dizziness and debilitation of patients. 12 months The presence of dizziness and debilitation are recorded as 'yes' or 'no'.
Trial Locations
- Locations (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
🇨🇳Jinan, Shandong, China