Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol

Study Overview
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Brief Summary
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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.

Official Title
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Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol：a Double-center, Prospective, Controlled Study

Conditions
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Gastroscopy, Feelings, Fasting

Intervention / Treatment
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* Other: Modified Fasting Group
* Other: Conventional Fasting Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Fasting Group<br>In this parallel group, subjects are performed a conventional fasting protocol which requires 6-8h fasting for solid, 2h for clear liquids. | Other: Conventional Fasting Group<br>* a conventional fasting protocol is applied to subjects.<br>|
| Experimental: Modified Fasting Group<br>In this test group, a new protocol of 4h fasting for rice porridge, 2h for clear liquids is applied to subjects. The rice porridge is commercially available (New Rice Porridge®, Charm Kitchen Food Co., Ltd., Q/NBBD0001S). The volume is 300ml, with the energy as 105kJ per 100g, and it can be eaten after being heated or at room temperature. | Other: Modified Fasting Group<br>* a new fasting protocol is applied to subjects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse events | number of gastroscopy procedures with adverse event divided by the number of all gastroscopy procedures | up to 1 week |