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

NCT05219136 | Completed

• 1 other identifier: Fasting time
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Gastroscopy; Feelings; Fasting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• incidence of adverse events

  up to 1 week

Study Arms (2)

Conventional Fasting Group

ACTIVE COMPARATOR

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

Modified Fasting Group

EXPERIMENTAL

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

Interventions

Modified Fasting Group OTHER

a new fasting protocol is applied to subjects.

Modified Fasting Group

Conventional Fasting Group OTHER

a conventional fasting protocol is applied to subjects.

Conventional Fasting Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No history of benign and malignant tumors (including carcinoma and adenoma) of upper GI (including esophagus, stomach and duodenum)

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead
• The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University: collaborator

Study Sites (2)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University

Luzhou, Sichuan, China

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Lei Xin, Dr

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

• Luo-wei Wang, PhD

  Changhai Hospital

  STUDY CHAIR

• Li Li, Dr

  The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: February 1, 2022
• Study Start: October 7, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)