- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03802006
Ultrasound Assessment of Gastric Contents in Fasted Surgical Patients With Previous Subtotal Gastrectomy
January 9, 2019 updated by: Seoul National University Hospital
Investigators assess the gastric contents by ultrasonography in fasted patients with previous subtotal gastrectomy.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tea Kyong Kim, M.D.,Ph. D.
- Phone Number: 82-2-870-2519
- Email: ktkktk@gmail.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 03080
- Recruiting
- Seoul National University Hospital
-
Contact:
- Tae Kyong Kim, MD
- Phone Number: 82-2-2072-2467
- Email: ktkktk@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- The preoperative fasted patients with previous subtotal gastrectomy
Exclusion Criteria:
- Other anatomical abnormality or mass of stomach except gastrectomy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
fasted patient with previous gastrectomy
The fasted patient with previous subtotal gastrectomy except exclusion criteria are included
|
Ultrasound assessment of gastric body is performed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Before the induction of anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Type of gastric content assessed by gastric ultrasound
Time Frame: Before the induction of anesthesia
|
The type of gastric content is assessed by gastric ultrasound; solid, fluid, empty
|
Before the induction of anesthesia
|
Cross section area of stomach body assessed by gastric ultrasound
Time Frame: Before the induction of anesthesia
|
Cross section area is assessed by gastric ultrasound in the supine and right lateral positions
|
Before the induction of anesthesia
|
Incidence of full stomach
Time Frame: Before the induction of anesthesia
|
It is determined if the contents is solid or the amount of fluid is large.
|
Before the induction of anesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tea Kyong Kim, M.D.,Ph. D., Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2018
Primary Completion (Anticipated)
November 15, 2020
Study Completion (Anticipated)
December 15, 2020
Study Registration Dates
First Submitted
January 3, 2019
First Submitted That Met QC Criteria
January 9, 2019
First Posted (Actual)
January 14, 2019
Study Record Updates
Last Update Posted (Actual)
January 14, 2019
Last Update Submitted That Met QC Criteria
January 9, 2019
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- L-2018-346
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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