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Reduction of Starvation Time Prior to Gastroscopy

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01670253
Acronym
RETIME
Enrollment
75
Registered
2012-08-22
Start date
2014-01-01
Completion date
2014-12-11
Last updated
2019-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Habile Adult Patients Referred to the Elective Gastroscopy

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.

Interventions

BEHAVIORALGroup 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.

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Number of uncomplicated examinationsparticipants will be followed for the duration of hospital stay, an expected average of 1 hour

Secondary

MeasureTime frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026