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Reduction of Starvation Time Prior to Gastroscopy (RETIME)

This study is not yet open for participant recruitment.
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
History of Changes
  Purpose

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.


Condition Intervention
Habile Adult Patients Referred to the Elective Gastroscopy
 Behavioral: Group 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Randomized, Double-blind, Controlled, Parallel-group Study Reduction of Starvation Time Prior to Gastroscopy

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600
Study Start Date: August 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670253

Contacts
Contact: Anton Bilenko, dr. 41161065 ext +45 Anton.Bilenko@ouh.regionsyddanmark.dk

Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Anton Bilenko, MD Odense University Hospital
  More Information

No publications provided

Responsible Party: Anton Bilenko, MD, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01670253     History of Changes
Other Study ID Numbers: S-20120069
Study First Received: August 14, 2012
Last Updated: August 21, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Starvation
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 23, 2013