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

Not Applicable

Completed

• Conditions: Gastroscopy; Fasting; Feelings
• Interventions: Other: Conventional Fasting Group; Other: Modified Fasting Group

• Registration Number: NCT05219136
• Lead Sponsor: Changhai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-07
• Study First Submitted: 2021-12-20
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-28
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Fasting Group	Conventional Fasting Group	In this parallel group, subjects are performed a conventional fasting protocol which requires 6-8h fasting for solid, 2h for clear liquids.
Modified Fasting Group	Modified Fasting Group	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
incidence of adverse events	up to 1 week	number of gastroscopy procedures with adverse event divided by the number of all gastroscopy procedures

Trial Locations

Locations (2)

The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University; 🇨🇳 Luzhou, Sichuan, China

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China