Reduction of Starvation Time Prior to Gastroscopy (RETIME)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Odense University Hospital
Sponsor:
Information provided by (Responsible Party):
Anton Bilenko, MD, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01670253
First received: August 14, 2012
Last updated: August 21, 2012
Last verified: August 2012

August 14, 2012
August 21, 2012
August 2012
December 2012   (final data collection date for primary outcome measure)
Number of uncomplicated examinations [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 hour ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01670253 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Reduction of Starvation Time Prior to Gastroscopy
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Diagnostic
Habile Adult Patients Referred to the Elective Gastroscopy
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.
  • 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.
    Intervention: Behavioral: Group 1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
600
January 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Anton Bilenko, dr. 41161065 ext +45 Anton.Bilenko@ouh.regionsyddanmark.dk
Not Provided
 
NCT01670253
S-20120069
No
Anton Bilenko, MD, Odense University Hospital
Odense University Hospital
Not Provided
Principal Investigator: Anton Bilenko, MD Odense University Hospital
Odense University Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP