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

Naval Military Medical University

Status: Completed

Conditions: Gastroscopy; Fasting; Feelings

Treatments: Other: Modified Fasting Group; Other: Conventional Fasting Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05219136

Fasting time

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Conventional Fasting Group

Active Comparator group

Description:

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

Treatment:

Other: Conventional Fasting Group

Modified Fasting Group

Experimental group

Description:

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.

Treatment:

Other: Modified Fasting Group