GastroparesisNCT03259841
Ultrasound Assessment of Gastric Contents in Fasted Patient Undergoing Cholecystectomy
An observational study of Gastroparesis, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
Investigators assess the gastric contents by ultrasonography in fasted patients undergoing cholecystectomy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Ultrasound assessment of gastric contet
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Oct 2017to 8 Feb 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for cholecystectomy are included.
Who may be able to join
- Patients scheduled for cholecystectomy
Who cannot join
- Presence of gastric anatomic abnormality or pathology
- A previous surgery of esophagus or stomach
- Current pregnancy
- Who could not lie in the right lateral decubitus (RLD) position
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 156-707
About this study
Investigators assess the gastric contents by ultrasonography in fasted patients undergoing cholecystectomy.
Read the detailed description
Investigators evaluate the gastric volume through cross sectional area and amount of clear fluid using Perlas grade by ultrasound in the supine and right lateral position of fasted patients undergoing cholecystectomy. Full stomach is regarded if solid gastric contents are detected or clear fluid is more than 1.5 ml/kg. The frequency of full stomach will be analyzed.
- Conditions
- Gastroparesis
- Being tested
- Ultrasound assessment of gastric contet
- 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 contetOther
Ultrasound assessment of gastric content is performed in fasted patient undergoing cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| Fasted patients for cholecyctectomy | The fasted patients for cholecyctectomy except exclusion criteria are included Receives: Other: Ultrasound assessment of gastric contet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of full stomach
The incidence of full stomach is assessed by using ultrasonography.
Measured: Before the induction of anesthesia
Secondary outcomes (3)
Cross sectional area of the stomach
The cross sectional area of the stomach is assessed by using ultrasonography in the supine and right lateral positions.
Measured: Before the induction of anesthesia
Volume of stomach
The volume of stomach is assessed using the following formula; volume of stomach (mL) = 27.0 + 14.6 x cross-sectional area (right lateral position) - 1.28 x age.
Measured: Before the induction of anesthesia
Type of gastric contents
The type of gastric contents is assessed using ultrasonography.
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 posted24 Aug 2017
- Study start31 Oct 2017
- Primary completion8 Feb 2019
- Study completion8 Feb 2019
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 GastroparesisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
- Investigators
- Jin-Young Hwang, M.D., Ph.D., Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259841
- Sponsor's protocol ID
- 2017-8-4
- Status last verified
- May 2019
- First submitted
- 4 Aug 2017
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang JE, Kim H, Won D, Lee JM, Jung JY, Min SW, Hwang JY. Ultrasound assessment of gastric content in fasted patients before elective laparoscopic cholecystectomy: a prospective observational single-cohort study. Can J Anaesth. 2020 Jul;67(7):810-816. doi: 10.1007/s12630-020-01668-7. Epub 2020 Apr 20.
PubMed 32314262
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Gastric Contents in Fasted Patient Undergoing Cholecystectomy
- ClinicalTrials.gov ID
- NCT03259841
- Acronym / sponsor ID
- 2017-8-4
- Conditions
- Gastroparesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 24 Aug 2017 (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 undergoing cholecystectomy.
Detailed description
Investigators evaluate the gastric volume through cross sectional area and amount of clear fluid using Perlas grade by ultrasound in the supine and right lateral position of fasted patients undergoing cholecystectomy. Full stomach is regarded if solid gastric contents are detected or clear fluid is more than 1.5 ml/kg. The frequency of full stomach will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fasted patients for cholecyctectomy | – | Other: Ultrasound assessment of gastric contetThe fasted patients for cholecyctectomy except exclusion criteria are included |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for cholecystectomy are included.
Key inclusion criteria (1 listed)
- Patients scheduled for cholecystectomy
Key exclusion criteria (4 listed)
- Presence of gastric anatomic abnormality or pathology
- A previous surgery of esophagus or stomach
- Current pregnancy
- Who could not lie in the right lateral decubitus (RLD) position
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 contetUltrasound assessment of gastric content is performed in fasted patient undergoing cholecystectomy. | Other | Fasted patients for cholecyctectomy |
Primary outcome
Incidence of full stomach
Time frame: Before the induction of anesthesia
The incidence of full stomach is assessed by using ultrasonography.
3 secondary outcomes
Cross sectional area of the stomach
Time frame: Before the induction of anesthesia
Volume of stomach
Time frame: Before the induction of anesthesia
Type of gastric contents
Time frame: Before the induction of anesthesia
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 21 May 2019.
- Derived from this study: PubMed 32314262Chang JE, Kim H, Won D, Lee JM, Jung JY, Min SW, Hwang JY. Ultrasound assessment of gastric content in fasted patients before elective laparoscopic cholecystectomy: a prospective observational single-cohort study. Can J Anaesth. 2020 Jul;67(7):810-816. doi: 10.1007/s12630-020-01668-7. Epub 2020 Apr 20.
- Individual participant dataSharing planned: No
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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.
Jin-Young Hwang, M.D., Ph.D. principal investigator
SMG-SNU Boramae Medical Center
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 SMG-SNU Boramae Medical Center 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 4 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 21 May 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?
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?
Incidence of full stomach (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?
On the ClinicalTrials.gov record for NCT03259841, 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 21 May 2019.