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

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.

Study Overview

• Status: Completed
• Conditions: Fasting; Feelings; Gastroscopy
• Intervention / Treatment: Other: Conventional Fasting Group; Other: Modified Fasting Group

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Changhai Hospital
  • Sichuan
    • Luzhou, Sichuan, China
      • The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Conventional Fasting Group; a conventional fasting protocol is applied to subjects.
Experimental: 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.	Other: Modified Fasting Group; a new fasting protocol is applied to subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University
• Investigators: Principal Investigator: Lei Xin, Dr, Changhai Hospital; Study Chair: Luo-wei Wang, PhD, Changhai Hospital; Principal Investigator: Li Li, Dr, The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 28, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Fasting time

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No