Reduction of Starvation Time Prior to Gastroscopy

NCT01670253 | Terminated

• 1 other identifier: S-20120069
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of uncomplicated examinations

  participants will be followed for the duration of hospital stay, an expected average of 1 hour

Secondary Outcomes (1)

• 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

Study Arms (2)

Group 2

NO INTERVENTION

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

Group 1

EXPERIMENTAL

* 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.

Behavioral: Group 1

Interventions

Group 1 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.

Group 1

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Officials

• Anton Bilenko, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 22, 2012
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 11, 2014
• Last Updated: August 29, 2019

Record last verified: 2019-08