Suspended

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

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What is being tested

Group 1

Behavioral
Who is being recruted

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: January 2014
See protocol details

Summary

Principal SponsorOdense University Hospital
Last updated: August 29, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2014

Actual date on which the first participant was enrolled.

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.

NCT01670253
Principal SponsorOdense University Hospital
Last updated: August 29, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

75 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
Age over 18 years
Sufficient knowledge of Danish to understand the written information
legally competent patients
3 exclusion criteria prevent from participating
Incapacitated patients
Patients with a history of pyloric stenosis (narrowing of the transition from stomach to the duodenum)
Patients with daily vomiting

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

No Intervention
6 hours of total fast for all solid and liquid food / drinks

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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SuspendedNo study centers