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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
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Habile Adult Patients Referred to the Elective Gastroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 14, 2012
    Last Updated
    August 27, 2019
    Sponsor
    Odense University Hospital
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    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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