NCT03259841

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 31, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2019

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

1.3 years

First QC Date

August 4, 2017

Last Update Submit

May 19, 2019

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

  • Incidence of full stomach

    The incidence of full stomach is assessed by using ultrasonography.

    Before the induction of anesthesia

Secondary Outcomes (3)

  • Cross sectional area of the stomach

    Before the induction of anesthesia

  • Volume of stomach

    Before the induction of anesthesia

  • Type of gastric contents

    Before the induction of anesthesia

Study Arms (1)

Fasted patients for cholecyctectomy

The fasted patients for cholecyctectomy except exclusion criteria are included

Other: Ultrasound assessment of gastric contet

Interventions

Ultrasound assessment of gastric contetOTHER

Ultrasound assessment of gastric content is performed in fasted patient undergoing cholecystectomy.

Fasted patients for cholecyctectomy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for cholecystectomy are included.

You may qualify if:

  • Patients scheduled for cholecystectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 32314262DERIVED

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jin-Young Hwang, M.D., Ph.D.

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

August 4, 2017

First Posted

August 24, 2017

Study Start

October 31, 2017

Primary Completion

February 8, 2019

Study Completion

February 8, 2019

Last Updated

May 21, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)