Pediatric Disorder Clinical Trial
Official title:
Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy: a Prospective Randomized Controlled Study
Verified date | December 2018 |
Source | Children's Hospital of Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Video capsule endoscopy (VCE) has become an established technique to investigate the presence of small bowel pathology. But the limited battery life of capsules can lead to incomplete small bowel visualization. There is a rationale to use prokinetic agents prior to VCE reduce the chances of an incomplete small bowel examination via decrease gastric transit time (GTT). Investigators are aimed to prospectively compare the completion rate of VCE in pediatric patients receiving prokinetic with those receiving no prokinetic.
Status | Completed |
Enrollment | 200 |
Est. completion date | November 1, 2018 |
Est. primary completion date | November 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Indications of capsule endoscopy; - Informed consent form obtained. Exclusion Criteria: - Contraindication of capsule endoscopy; - Domperidone allergy; - Unwilling to participate. |
Country | Name | City | State |
---|---|---|---|
China | Children's hospital of Fudan university | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Fudan University |
China,
Mcfarlane M, Liu B, Nwokolo C. Domperidone prolongs oral to duodenal transit time in video capsule endoscopy. Eur J Clin Pharmacol. 2018 Apr;74(4):521-524. doi: 10.1007/s00228-017-2399-8. Epub 2017 Dec 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Completion rate of capsule endoscopy | CE was considered complete when the cecum was reached within recording time. | assessed through study completion, an average of 1 year | |
Secondary | Gastric transit time (GTT) | The GTT was defined as the time, in minutes, from the first image of the stomach until the first image of the duodenum. | assessed through study completion, an average of 1 year | |
Secondary | small bowel transit time (SBTT) | The SBTT was defined as the passage time, in minutes, from the first image of the duodenum until the first image of the cecum. | assessed through study completion, an average of 1 year |
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