Reduction of Starvation Time Prior to Gastroscopy

NCT ID: NCT01670253

Last Updated: 2019-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2014-12-11

Brief Summary

The primary objective is to investigate whether intake of approximately 200 ml of sugary fluid 2 hours before the scheduled gastroscopy of the abdomen can reduce the discomfort of fasting period for patients without reducing the quality of the study.

Current standard for fasting and fluid intake before gastroscopy is completely fasting 6 hours before the study. Studies in patients in general anesthesia has been found that it does not increase the risk of aspiration of stomach content during the operation by allowing the patient to drink up to 2 hours prior to anesthesia induction. There are no studies that have examined the quality gastroscopy using this fasting procedure. Some studies show that intake of sugary liquids do not have significant effect on gastric emptying.

There are not deemed to be ethical problems with this study, as it seeks to show that a more lenient standard procedure in endoscopy is as safe as the established. The study is considered safe.

Conditions

Habile Adult Patients Referred to the Elective Gastroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Group 2

6 hours of total fast for all solid and liquid food / drinks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group 1

• 6 hour fast from all solid foods and milk beverages
• 2-hour thirst period before examination (patient may be in the period from 6 to 2 hours before the study drink any kind of clear liquids, ie liquids containing no milk products)
• Approximately 2 hours before the time of examination please drink a glass (about 2 cups) clear sugary liquid - eg lemonade, apple juice, iced tea, soda or the like.

Group Type: EXPERIMENTAL

Group 1

Intervention Type: BEHAVIORAL

• 6 hour fast from all solid foods and milk beverages
• 2-hour thirst period before examination (patient may be in the period from 6 to 2 hours before the study drink any kind of clear liquids, ie liquids containing no milk products)
• Approximately 2 hours before the time of examination please drink a glass (about 2 cups) clear sugary liquid - eg lemonade, apple juice, iced tea, soda or the like.

Interventions

Group 1

• 6 hour fast from all solid foods and milk beverages
• 2-hour thirst period before examination (patient may be in the period from 6 to 2 hours before the study drink any kind of clear liquids, ie liquids containing no milk products)
• Approximately 2 hours before the time of examination please drink a glass (about 2 cups) clear sugary liquid - eg lemonade, apple juice, iced tea, soda or the like.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age over 18 years
• Sufficient knowledge of Danish to understand the written information
• legally competent patients

Exclusion Criteria

• Patients with a history of pyloric stenosis (narrowing of the transition from stomach to the duodenum)
• Incapacitated patients
• Patients with daily vomiting.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anton Bilenko, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anton Bilenko, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Other Identifiers

S-20120069

Identifier Type: -

Identifier Source: org_study_id