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Ultrasound Assessment of Gastric Contents in Fasted Patient Undergoing Cholecystectomy

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ClinicalTrials.gov Identifier: NCT03259841
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Jin-Young Hwang, SMG-SNU Boramae Medical Center

Brief Summary:
Investigators assess the gastric contents by ultrasonography in fasted patients undergoing cholecystectomy.

Condition or disease Intervention/treatment
Gastroparesis Other: Ultrasound assessment of gastric contet

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 Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound Assessment of Gastric Contents in Fasted Patient Undergoing Cholecystectomy
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : September 14, 2018
Estimated Study Completion Date : October 14, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Fasted patients for cholecyctectomy
The fasted patients for cholecyctectomy except exclusion criteria are included
Other: Ultrasound assessment of gastric contet
Ultrasound assessment of gastric content is performed in fasted patient undergoing cholecystectomy.




Primary Outcome Measures :
  1. Incidence of full stomach [ Time Frame: Before the induction of anesthesia ]
    The incidence of full stomach is assessed by using ultrasonography.


Secondary Outcome Measures :
  1. Cross sectional area of the stomach [ Time Frame: Before the induction of anesthesia ]
    The cross sectional area of the stomach is assessed by using ultrasonography in the supine and right lateral positions.

  2. Volume of stomach [ Time Frame: Before the induction of anesthesia ]
    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.

  3. Type of gastric contents [ Time Frame: Before the induction of anesthesia ]
    The type of gastric contents is assessed using ultrasonography.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for cholecystectomy are included.
Criteria

Inclusion Criteria:

  • Patients scheduled for cholecystectomy

Exclusion Criteria:

  • History of gastrectomy
  • Anatomical abnormalities or mass of stomach

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259841


Contacts
Contact: Jin-Young Hwang, M.D., Ph.D. 82-2-870-2518 mistyblue15@naver.com

Locations
Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 156-707
Contact: Jin-Young Hwang, M.D.    +82-2-870-2518    mistyblue15@naver.com   
Sponsors and Collaborators
SMG-SNU Boramae Medical Center
Investigators
Principal Investigator: Jin-Young Hwang, M.D., Ph.D. SMG-SNU Boramae Medical Center

Responsible Party: Jin-Young Hwang, associate professor, SMG-SNU Boramae Medical Center
ClinicalTrials.gov Identifier: NCT03259841     History of Changes
Other Study ID Numbers: 2017-8-4
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms