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| Name | Class |
|---|---|
| The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Fasting Group | Active Comparator | In this parallel group, subjects are performed a conventional fasting protocol which requires 6-8h fasting for solid, 2h for clear liquids. |
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| Modified Fasting Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Fasting Group | Other | a new fasting protocol is applied to subjects. |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lei Xin, Dr | Changhai Hospital | Principal Investigator |
| Luo-wei Wang, PhD | Changhai Hospital | Study Chair |
| Li Li, Dr | The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Shanghai | Shanghai Municipality | 200433 | China | ||
| The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University |
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| ID | Term |
|---|---|
| D005215 | Fasting |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| Conventional Fasting Group |
| Other |
a conventional fasting protocol is applied to subjects. |
|
| Luzhou |
| Sichuan |
| China |