Reduction of Starvation Time Prior to Gastroscopy (RETIME)
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.
Habile Adult Patients Referred to the Elective Gastroscopy
Behavioral: Group 1
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Diagnostic
|Official Title:||Randomized, Double-blind, Controlled, Parallel-group Study Reduction of Starvation Time Prior to Gastroscopy|
- Number of uncomplicated examinations [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 hour ] [ Designated as safety issue: Yes ]
- Reduction of discomfort for the patients according to the survey. [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 hour ] [ Designated as safety issue: No ]
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
No Intervention: Group 2
6 hours of total fast for all solid and liquid food / drinks
Experimental: Group 1
Behavioral: Group 1
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670253
|Contact: Anton Bilenko, dr.||41161065 ext +45||Anton.Bilenko@ouh.regionsyddanmark.dk|
|Principal Investigator:||Anton Bilenko, MD||Odense University Hospital|