GastroparesisNCT03802006
Ultrasound Assessment of Gastric Contents in Fasted Surgical Patients With Previous Subtotal Gastrectomy
An observational study of Gastroparesis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Investigators assess the gastric contents by ultrasonography in fasted patients with previous subtotal gastrectomy. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Ultrasound assessment of gastric content
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2018to 15 Dec 2020
- Phase
- Observational
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will conduct a study targeting the patients with previous subtotal gastectomy among the patients fasted for an operation under general, spinal or MAC anesthesia, except people with other anatomical abnormality or mass of stomach except gastrectomy
Who may be able to join
- The preoperative fasted patients with previous subtotal gastrectomy
Who cannot join
- Other anatomical abnormality or mass of stomach except gastrectomy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Tae Kyong Kim, MD, 82-2-2072-2467, ktkktk@gmail.com
About this study
Investigators assess the gastric contents by ultrasonography in fasted patients with previous subtotal gastrectomy.
Read the detailed description
Investigators evaluate the gastric contents by ultrasonography in fasted patients with previous subtotal gastrectomy, quantitatively and qualitatively. The frequency of visualization fully will be also analyzed.
- Conditions
- Gastroparesis
- Being tested
- Ultrasound assessment of gastric content
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound assessment of gastric contentDiagnostic test
Ultrasound assessment of gastric body is performed
| Study group | Role | What they receive |
|---|---|---|
| fasted patient with previous gastrectomy | The fasted patient with previous subtotal gastrectomy except exclusion criteria are included Receives: Diagnostic Test: Ultrasound assessment of gastric content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of full cross section image
The gastric remnant body is assessed by ultrasound and the incidence of cross sectional image visualized fully is evaluated
Measured: Before the induction of anesthesia
Secondary outcomes (3)
Type of gastric content assessed by gastric ultrasound
The type of gastric content is assessed by gastric ultrasound; solid, fluid, empty
Measured: Before the induction of anesthesia
Cross section area of stomach body assessed by gastric ultrasound
Cross section area is assessed by gastric ultrasound in the supine and right lateral positions
Measured: Before the induction of anesthesia
Incidence of full stomach
It is determined if the contents is solid or the amount of fluid is large.
Measured: Before the induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start15 Nov 2018
- Primary completion15 Nov 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tea Kyong Kim, M.D.,Ph. D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802006
- Sponsor's protocol ID
- L-2018-346
- Status last verified
- Oct 2018
- First submitted
- 3 Jan 2019
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Gastric Contents in Fasted Surgical Patients With Previous Subtotal Gastrectomy
- ClinicalTrials.gov ID
- NCT03802006
- Acronym / sponsor ID
- L-2018-346
- Conditions
- Gastroparesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 14 Jan 2019 (actual)
- 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.
Investigators assess the gastric contents by ultrasonography in fasted patients with previous subtotal gastrectomy.
Detailed description
Investigators evaluate the gastric contents by ultrasonography in fasted patients with previous subtotal gastrectomy, quantitatively and qualitatively. The frequency of visualization fully will be also analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fasted patient with previous gastrectomy | – | Diagnostic Test: Ultrasound assessment of gastric contentThe fasted patient with previous subtotal gastrectomy except exclusion criteria are included |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will conduct a study targeting the patients with previous subtotal gastectomy among the patients fasted for an operation under general, spinal or MAC anesthesia, except people with other anatomical abnormality or mass of stomach except gastrectomy
Key inclusion criteria (1 listed)
- The preoperative fasted patients with previous subtotal gastrectomy
Key exclusion criteria (1 listed)
- Other anatomical abnormality or mass of stomach except gastrectomy
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 |
|---|---|---|
| Ultrasound assessment of gastric contentUltrasound assessment of gastric body is performed | Diagnostic test | fasted patient with previous gastrectomy |
Primary outcome
Incidence of full cross section image
Time frame: Before the induction of anesthesia
The gastric remnant body is assessed by ultrasound and the incidence of cross sectional image visualized fully is evaluated
3 secondary outcomes
Type of gastric content assessed by gastric ultrasound
Time frame: Before the induction of anesthesia
Cross section area of stomach body assessed by gastric ultrasound
Time frame: Before the induction of anesthesia
Incidence of full stomach
Time frame: Before the induction of anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
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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.
Tea Kyong Kim, M.D.,Ph. D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis, run by Seoul National University Hospital at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 14 Jan 2019. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tea Kyong Kim, M.D.,Ph. D. (82-2-870-2519, ktkktk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of full cross section image (time frame: Before the induction of anesthesia). 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 14 Jan 2019.