|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT02555228 |
|
Date of registration:
|
13/09/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Small Volume Simethicone Before Gastroscopy: Any Benefit?
|
|
Scientific title:
|
Benefits of Premedication With Small Volume Simethicone Solution Before Diagnostic Gastroscopy: A Randomized Endoscopist-blinded Prospective Study |
|
Date of first enrolment:
|
August 2015 |
|
Target sample size:
|
54 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02555228 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 2/Phase 3
|
|
|
Countries of recruitment
|
|
Singapore
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Planned for an elective diagnostic gastroscopy by the attending gastroenterologist
- Age of at least 21 years old
- Mentally competent and able to provide informed consent
Exclusion Criteria:
- Category A patients (incarcerated prisoners)
- adults who are unable to give their own informed consent due to lack of mental
capacity
- suspected gastrointestinal bleeding
- suspected impacted foreign material
- suspected gastric outlet obstruction
- suspected esophageal obstruction
- history of dysphagia
- known hypersensitivity to simethicone
- previous gastrectomy
Age minimum:
21 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Lesion of Stomach
|
|
Intervention(s)
|
|
Other: Water
|
|
Drug: Simethicone
|
|
Primary Outcome(s)
|
|
Total Cumulative Mucosal Visibility Score
[Time Frame: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.]
|
|
Secondary Outcome(s)
|
|
Mucosal Visibility Score Per Area as Determined by Mc Nally Score:
[Time Frame: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.]
|
|
Volume of Additional Manual Flushes Required During Endoscopy in Mls
[Time Frame: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.]
|
|
Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution
[Time Frame: Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours]
|
|
Secondary ID(s)
|
|
CGH-QIPSMJ
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|