Fasting Clinical Trial
Official title:
Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol:a Double-center, Prospective, Controlled Study
Verified date | May 2022 |
Source | Changhai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This double-center, prospective, interventional study aims to include 200 gastroscopic procedures and investigate the relationship between fasting time and feeling of subjects. The subjects will all receive examination between 10:30 to 11:30am. In the control group, the subjects are required to start the fast at 10:00pm the day before examination and can not drink water after 8:00am on the day of examination. In the test group, the subjects are required to have customized rice congee before 6:30am on the examination day and can not drink water after 8:00am. All subjects complete questionnaire which include discomfort and willingness to accept the same fasting regimen.
Status | Completed |
Enrollment | 200 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - No history of benign and malignant tumors (including carcinoma and adenoma) of upper GI (including esophagus, stomach and duodenum) Exclusion Criteria: - Subjects that cannot stand the gastroscopy procedure or cannot cooperate with endoscopists - Emergency endoscopy and therapeutic endoscopy - Subjects with history of esophageal or stomach surgery or endoscopic surgery - Pregnant - Subjects that refuse to cooperate with data collection or sign the informed consent |
Country | Name | City | State |
---|---|---|---|
China | The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University | Luzhou | Sichuan |
China | Changhai Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital | The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | subject's discomfort | The feeling of the subject during the examination. 1) the score of mucosal restriction observed under gastroscope 2)the score of discomfort before gastroscopy 3)the score of discomfort during gastroscopy process. The discomfort feeling indicator was obtained from subject through a VAS scale. The score of mucosal restriction was obtained from endoscopists. | up to 1 week | |
Secondary | incidence of adverse events | number of gastroscopy procedures with adverse event divided by the number of all gastroscopy procedures | up to 1 week |
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