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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mannitol | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polyethylene glycol | Drug | Experimental group was given polyethylene glycol as oral contrast agent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance of two neutral oral contrast agents in CT enterography. | The assessment system includes six parts.
| 12 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanqing Li, PhD, MD | Contact | 86-531-82169236 | liyanqing@sdu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yanqing Li, PhD, MD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Qilu Hospital, Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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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.
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| mannitol | Drug | Active comparator group was given mannitol as oral contrast agent. |
|
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 |
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D013402 | Sugar Alcohols |
| D002241 | Carbohydrates |