Reduction of Starvation Time Prior to Gastroscopy (RETIME)

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

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.

Study Overview

• Status: Terminated
• Conditions: Habile Adult Patients Referred to the Elective Gastroscopy
• Intervention / Treatment: Behavioral: Group 1

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of uncomplicated examinations	participants will be followed for the duration of hospital stay, an expected average of 1 hour

Secondary Outcome Measures

Outcome Measure	Time 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

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Principal Investigator: Anton Bilenko, MD, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 11, 2014

Study Registration Dates

• First Submitted: August 14, 2012
• First Submitted That Met QC Criteria: August 21, 2012
• First Posted (Estimate): August 22, 2012

Study Record Updates

• Last Update Posted (Actual): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Starvation
• Other Study ID Numbers: S-20120069

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No