Reduction of Starvation Time Prior to Gastroscopy

Habile Adult Patients Referred to the Elective Gastroscopy Clinical Trial

— RETIME  

Official title:

Randomized, Double-blind, Controlled, Parallel-group Study Reduction of Starvation Time Prior to Gastroscopy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01670253
• Other study ID #: S-20120069
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: December 11, 2014

Study information

• Verified date: August 2019
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: December 11, 2014
• Est. primary completion date: December 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Habile Adult Patients Referred to the Elective Gastroscopy
• Starvation

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of uncomplicated examinations		participants will be followed for the duration of hospital stay, an expected average of 1 hour
Secondary	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