Reduction of Starvation Time Prior to Gastroscopy (RETIME)
Primary Purpose
Habile Adult Patients Referred to the Elective Gastroscopy
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group 1
Sponsored by
About this trial
This is an interventional diagnostic trial for Habile Adult Patients Referred to the Elective Gastroscopy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Group 2
Group 1
Arm Description
6 hours of total fast for all solid and liquid food / drinks
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.
Outcomes
Primary Outcome Measures
Number of uncomplicated examinations
Secondary Outcome Measures
Reduction of discomfort for the patients according to the survey.
Full Information
NCT ID
NCT01670253
First Posted
August 14, 2012
Last Updated
August 27, 2019
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01670253
Brief Title
Reduction of Starvation Time Prior to Gastroscopy
Acronym
RETIME
Official Title
Randomized, Double-blind, Controlled, Parallel-group Study Reduction of Starvation Time Prior to Gastroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Not enough facilities to study
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
December 1, 2014 (Actual)
Study Completion Date
December 11, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Habile Adult Patients Referred to the Elective Gastroscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 2
Arm Type
No Intervention
Arm Description
6 hours of total fast for all solid and liquid food / drinks
Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group 1
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of uncomplicated examinations
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 1 hour
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anton Bilenko, MD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Reduction of Starvation Time Prior to Gastroscopy
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