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Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy

NCT ID: NCT03662113

Last Updated: 2018-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-11-01

Brief Summary

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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.

Detailed Description

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Eligible children were randomly divided into two groups: domperidone prior to VCE and water prior to VCE. The primary outcome measure was the completion rate. Secondary outcome measures included the GTT and SBTT.

Conditions

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Capsule Endoscopy Pediatric Disorder

Keywords

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domperidone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Experimental: Domperidone

5ml domperidone prior to VCE

Group Type EXPERIMENTAL

Domperidone

Intervention Type DRUG

5ml Domperidone prior to VCE

Control: water

5ml warm water prior to VCE

Group Type OTHER

water

Intervention Type DIETARY_SUPPLEMENT

5ml water prior to VCE

Interventions

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Domperidone

5ml Domperidone prior to VCE

Intervention Type DRUG

water

5ml water prior to VCE

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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simethicone simethicone

Eligibility Criteria

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Inclusion Criteria

* Indications of capsule endoscopy;
* Informed consent form obtained.

Exclusion Criteria

* Contraindication of capsule endoscopy;
* Domperidone allergy;
* Unwilling to participate.
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Ying HUANG

The director of gastroenterology of Children's Hospital of Fudan University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ying Huang, doctor

Role: STUDY_DIRECTOR

Children's Hospital of Fudan University

Locations

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Children's hospital of Fudan university

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 29222714 (View on PubMed)

Wu J, Ye Z, Xue A, Huang Y. Can domperidone decrease transit time of pediatric video capsule endoscopy? A randomized controlled trial. Transl Pediatr. 2021 Feb;10(2):344-349. doi: 10.21037/tp-20-273.

Reference Type DERIVED
PMID: 33708520 (View on PubMed)

Other Identifiers

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DomperidoneVCE

Identifier Type: -

Identifier Source: org_study_id