Habile Adult Patients Referred to the Elective GastroscopyRETIMENCT01670253
Reduction of Starvation Time Prior to Gastroscopy
A study testing Group 1 in people with Habile Adult Patients Referred to the Elective Gastroscopy, run by Odense University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Habile Adult Patients Referred to the Elective Gastroscopy
- What is being tested?
- Group 1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 11 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Sufficient knowledge of Danish to understand the written information
- legally competent patients
Who cannot join
- Patients with a history of pyloric stenosis (narrowing of the transition from stomach to the duodenum)
- Incapacitated patients
- Patients with daily vomiting.
About this study
Official title: 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.
- Being tested
- Group 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Behavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | No intervention | 6 hours of total fast for all solid and liquid food / drinks |
| Group 1 | Experimental | * 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. Receives: Behavioral: Group 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of uncomplicated examinations
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 hour
Secondary outcomes (1)
Reduction of discomfort for the patients according to the survey.
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study start1 Jan 2014
- Primary completion1 Dec 2014
- Study completion11 Dec 2014
Why it stopped: Not enough facilities to study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Habile Adult Patients Referred to the Elective GastroscopyStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anton Bilenko, MD, Odense University Hospital
- Investigators
- Anton Bilenko, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670253
- Sponsor's protocol ID
- S-20120069
- Acronym
- RETIME
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2012
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Controlled, Parallel-group Study Reduction of Starvation Time Prior to Gastroscopy
- ClinicalTrials.gov ID
- NCT01670253
- Acronym / sponsor ID
- RETIME / S-20120069
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough facilities to study
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Dec 2014 (actual)
- Study completion
- 11 Dec 2014 (actual)
- First posted
- 22 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 2 | No intervention | –6 hours of total fast for all solid and liquid food / drinks |
| Group 1 | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years
- Sufficient knowledge of Danish to understand the written information
- legally competent patients
Key exclusion criteria (3 listed)
- Patients with a history of pyloric stenosis (narrowing of the transition from stomach to the duodenum)
- Incapacitated patients
- Patients with daily vomiting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Group 1 |
Primary outcome
Number of uncomplicated examinations
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 hour
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Not enough facilities to study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anton Bilenko, MD principal investigator
Odense University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 in people with Habile Adult Patients Referred to the Elective Gastroscopy, run by Odense University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough facilities to study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.