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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05219136
• Other study ID #: Fasting time
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fasting
• Feelings
• Gastroscopy

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