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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05219136
Other study ID # Fasting time
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 7, 2021
Est. completion date December 31, 2021

Study information

Verified date May 2022
Source Changhai Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Modified Fasting Group
a new fasting protocol is applied to subjects.
Conventional Fasting Group
a conventional fasting protocol is applied to subjects.

Locations

Country Name City State
China The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University Luzhou Sichuan
China Changhai Hospital Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Changhai Hospital The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University

Country where clinical trial is conducted

China, 

Outcome

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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