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Completed

NCT Number: NCT05219136

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

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.

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Key information

Conditions

Gastroscopy Behavior Fasting Feeding Behavior Feelings

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Fasting Group

Other

a new fasting protocol is applied to subjects.

Conventional Fasting Group

Other

a conventional fasting protocol is applied to subjects.

Primary outcomes

  1. subject's discomfort

    Time frame: 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 outcomes

  1. incidence of adverse events

    Time frame: up to 1 week

    number of gastroscopy procedures with adverse event divided by the number of all gastroscopy procedures

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University

Registry information

Official study title

Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol：a Double-center, Prospective, Controlled Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 1, 2022
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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