ClinicalTrials.gg
TerminatedNCT01670253RETIMEUpdated Aug 29, 2019

Reduction of Starvation Time Prior to Gastroscopy

An interventional study of Group 1 in Habile Adult Patients Referred to the Elective Gastroscopy, sponsored by Odense University Hospital. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-29.

Sponsored by Odense University Hospital · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Not enough facilities to study
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Habile Adult Patients Referred to the Elective Gastroscopy
03

In context

Lead sponsor

Odense University Hospital is the lead sponsor of 477 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with a history of pyloric stenosis (narrowing of the transition from stomach to the duodenum)
  • Incapacitated patients
  • Patients with daily vomiting.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
75 participants (actual)

Study arms

  • No intervention
    Group 2

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

  • Experimental
    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.

    Behavioral: Group 1

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.

06

What researchers measure

Primary outcomes

  1. Number of uncomplicated examinations

    Time frame: 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.

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2014 to primary completion in Dec 2014, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2012
First posted
Aug 22, 2012
StartActual
Jan 1, 2014
Primary completionActual
Dec 1, 2014
CompletionActual
Dec 11, 2014
Last update
Aug 29, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01670253
Responsible party
Anton Bilenko, MD (MD, Odense University Hospital) — Principal investigator
First posted
Aug 22, 2012
Start date
Jan 1, 2014
Primary completion
Dec 1, 2014
Completion
Dec 11, 2014
Last update
Aug 29, 2019

Study contacts

Anton Bilenko, MD
principal investigator · Odense University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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