Upper Gastrointestinal SymptomssafendoscopyNCT01492296
Endoscopy With Short Fasting
A study testing endoscopy after short fasting and conventional fasting in people with Upper Gastrointestinal Symptoms, run by Universidade de Passo Fundo at 1 site in Brazil.
Trial summary
Upper gastrointestinal (GI) endoscopy is widely used in the clinical practice. An empty stomach is required to ensure quality and safety. For this reason, endoscopy is conventionally performed after 8 or more hours of fasting, which is potentially related to discomfort to the patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper Gastrointestinal Symptoms
- What is being tested?
- endoscopy after short fasting and conventional fasting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2011to Nov 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective endoscopy
Who cannot join
- poor clinical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Quality and Comfort of Upper Gastrointestinal Endoscopy With Conscious Sedation After Fasting for Two Hours
Upper gastrointestinal (GI) endoscopy is widely used in the clinical practice. An empty stomach is required to ensure quality and safety. For this reason, endoscopy is conventionally performed after 8 or more hours of fasting, which is potentially related to discomfort to the patients. In recent studies, surgical cholecystectomy has been described to be safe after two hours of fasting on liquids. The aim of this study is to assess safety, quality and comfort of upper GI endoscopy after two hours of fasting.
- Conditions
- Upper Gastrointestinal Symptoms
- Being tested
- endoscopy after short fasting, conventional fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopy after short fastingProcedure or surgery
patients were evaluated with endoscopy after fasting for two hours
conventional fastingProcedure or surgery
patients were evaluated after fasting for 8 hours
| Study group | Role | What they receive |
|---|---|---|
| conventional fasting | Active comparator | patients were evaluated after fasting for 8 hours Receives: Procedure: conventional fasting |
| Short fasting | Experimental | patients who were evaluated with endoscopy after fasting for two hours Receives: Procedure: endoscopy after short fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety
safety of endoscopy after fasting for two hours will be assessed by means of a questionnaire replied by the endoscopists, questioning occurrence of aspiration and regurgitation of gastric contents into the esophagus.
Measured: 10 min (endoscopy duration)
Secondary outcomes (2)
quality
Quality of endoscopy will be assessed by means of a questionnaire replied by the endoscopists, including (1) presence of liquid in the gastric lumen (2) quality of mucosa visualization (3)period needed for gastric aspiration
Measured: 10 min (endoscopy duration)
Endoscopy comfort
Endoscopy comfort will be evaluated by the patients by means of a questionnaire replied after the procedures. It will include questions about thirst, hunger, anxiety, weakness and nausea.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal SymptomsStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade de Passo Fundo
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Principal investigator, Fernando Fornari, Universidade de Passo Fundo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492296
- Sponsor's protocol ID
- safendoscopy
- Acronym
- safendoscopy
- Status last verified
- Dec 2011
- First submitted
- 5 Dec 2011
- Last updated
- 14 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Koeppe AT, Lubini M, Bonadeo NM, Moraes I Jr, Fornari F. Comfort, safety and quality of upper gastrointestinal endoscopy after 2 hours fasting: a randomized controlled trial. BMC Gastroenterol. 2013 Nov 9;13:158. doi: 10.1186/1471-230X-13-158.
PubMed 24209639
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Quality and Comfort of Upper Gastrointestinal Endoscopy With Conscious Sedation After Fasting for Two Hours
- ClinicalTrials.gov ID
- NCT01492296
- Acronym / sponsor ID
- safendoscopy / safendoscopy
- Conditions
- Upper Gastrointestinal Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Universidade de Passo FundoUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- Mar 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 14 Dec 2011 (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.
Upper gastrointestinal (GI) endoscopy is widely used in the clinical practice. An empty stomach is required to ensure quality and safety. For this reason, endoscopy is conventionally performed after 8 or more hours of fasting, which is potentially related to discomfort to the patients. In recent studies, surgical cholecystectomy has been described to be safe after two hours of fasting on liquids. The aim of this study is to assess safety, quality and comfort of upper GI endoscopy after two hours of fasting.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional fasting | Active comparator | Procedure: conventional fastingpatients were evaluated after fasting for 8 hours |
| Short fasting | Experimental | Procedure: endoscopy after short fastingpatients who were evaluated with endoscopy after fasting for two hours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective endoscopy
Key exclusion criteria (1 listed)
- poor clinical condition
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 |
|---|---|---|
| endoscopy after short fastingpatients were evaluated with endoscopy after fasting for two hours | Procedure or surgery | Short fasting |
| conventional fastingpatients were evaluated after fasting for 8 hours | Procedure or surgery | conventional fasting |
Primary outcome
safety
Time frame: 10 min (endoscopy duration)
safety of endoscopy after fasting for two hours will be assessed by means of a questionnaire replied by the endoscopists, questioning occurrence of aspiration and regurgitation of gastric contents into the esophagus.
2 secondary outcomes
quality
Time frame: 10 min (endoscopy duration)
Endoscopy comfort
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2011.
- Derived from this study: PubMed 24209639Koeppe AT, Lubini M, Bonadeo NM, Moraes I Jr, Fornari F. Comfort, safety and quality of upper gastrointestinal endoscopy after 2 hours fasting: a randomized controlled trial. BMC Gastroenterol. 2013 Nov 9;13:158. doi: 10.1186/1471-230X-13-158.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopy after short fasting and conventional fasting in people with Upper Gastrointestinal Symptoms, run by Universidade de Passo Fundo at 1 site in Brazil.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
safety (time frame: 10 min (endoscopy duration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01492296, which also lists 1 linked publication.
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 14 Dec 2011.