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

NCT ID: NCT05219136

Last Updated: 2022-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-07

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Gastroscopy Feelings Fasting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Conventional Fasting Group

Intervention Type OTHER

a conventional fasting protocol is applied to subjects.

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.

Group Type EXPERIMENTAL

Modified Fasting Group

Intervention Type OTHER

a new fasting protocol is applied to subjects.

Interventions

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Modified Fasting Group

a new fasting protocol is applied to subjects.

Intervention Type OTHER

Conventional Fasting Group

a conventional fasting protocol is applied to subjects.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University

UNKNOWN

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Director of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lei Xin, Dr

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Luo-wei Wang, PhD

Role: STUDY_CHAIR

Changhai Hospital

Li Li, Dr

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University

Locations

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Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status

The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University

Luzhou, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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Fasting time

Identifier Type: -

Identifier Source: org_study_id

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