Reduction of Starvation Time Prior to Gastroscopy

Not Applicable

Terminated

• Conditions: Habile Adult Patients Referred to the Elective Gastroscopy
• Interventions: Behavioral: Group 1

• Registration Number: NCT01670253
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-22
• Study Start: 2014-01-01
• Primary Completion: 2014-12-01
• Study Completion: 2014-12-11
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	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.

Primary Outcome Measures

Name	Time	Method
Number of uncomplicated examinations	participants will be followed for the duration of hospital stay, an expected average of 1 hour

Secondary Outcome Measures

Name	Time	Method
Reduction of discomfort for the patients according to the survey.	participants will be followed for the duration of hospital stay, an expected average of 1 hour