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Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy

Sponsor
Children's Hospital of Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT03662113
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
12
Actual Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy: a Prospective Randomized Controlled Study
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Nov 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: Domperidone

5ml domperidone prior to VCE

Drug: Domperidone
5ml Domperidone prior to VCE
Other Names:
  • simethicone

    		•
    Other: Control: water

    5ml warm water prior to VCE

    Dietary Supplement: water
    5ml water prior to VCE
    Other Names:
  • simethicone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Completion rate of capsule endoscopy [assessed through study completion, an average of 1 year]

      CE was considered complete when the cecum was reached within recording time.

    Secondary Outcome Measures

    1. Gastric transit time (GTT) [assessed through study completion, an average of 1 year]

      The GTT was defined as the time, in minutes, from the first image of the stomach until the first image of the duodenum.

    2. small bowel transit time (SBTT) [assessed through study completion, an average of 1 year]

      The SBTT was defined as the passage time, in minutes, from the first image of the duodenum until the first image of the cecum.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Indications of capsule endoscopy;

    • Informed consent form obtained.

    Exclusion Criteria:

    • Contraindication of capsule endoscopy;

    • Domperidone allergy;

    • Unwilling to participate.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's hospital of Fudan university Shanghai Shanghai China 201102

    Sponsors and Collaborators

    • Children's Hospital of Fudan University

    Investigators

    • Study Director: Ying Huang, doctor, Children's Hospital of Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ying HUANG, The director of gastroenterology of Children's Hospital of Fudan University, Children's Hospital of Fudan University
    ClinicalTrials.gov Identifier:
    NCT03662113
    Other Study ID Numbers:
    • DomperidoneVCE
    First Posted:
    Sep 7, 2018
    Last Update Posted:
    Dec 17, 2018
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ying HUANG, The director of gastroenterology of Children's Hospital of Fudan University, Children's Hospital of Fudan University
    domperidone
    Additional relevant MeSH terms:
    Domperidone
    Simethicone

    Study Results

    No Results Posted as of Dec 17, 2018