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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05219136

Enrollment

200

Registered

2022-02-01

Start date

2021-10-07

Completion date

2021-12-31

Last updated

2022-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fasting, Feelings, Gastroscopy

Brief 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.

Interventions

OTHERModified Fasting Group

a new fasting protocol is applied to subjects.

OTHERConventional Fasting Group

a conventional fasting protocol is applied to subjects.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
subject's discomfort	up to 1 week	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.

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026