NCT03802006

Brief Summary

Investigators assess the gastric contents by ultrasonography in fasted patients with previous subtotal gastrectomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

January 14, 2019

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

January 3, 2019

Last Update Submit

January 9, 2019

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

  • 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

    Before the induction of anesthesia

Secondary Outcomes (3)

  • Type of gastric content assessed by gastric ultrasound

    Before the induction of anesthesia

  • Cross section area of stomach body assessed by gastric ultrasound

    Before the induction of anesthesia

  • Incidence of full stomach

    Before the induction of anesthesia

Study Arms (1)

fasted patient with previous gastrectomy

The fasted patient with previous subtotal gastrectomy except exclusion criteria are included

Diagnostic Test: Ultrasound assessment of gastric content

Interventions

Ultrasound assessment of gastric contentDIAGNOSTIC_TEST

Ultrasound assessment of gastric body is performed

fasted patient with previous gastrectomy

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • The preoperative fasted patients with previous subtotal gastrectomy

You may not qualify if:

  • Other anatomical abnormality or mass of stomach except gastrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Tea Kyong Kim, M.D.,Ph. D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tea Kyong Kim, M.D.,Ph. D.

CONTACT

82-2-870-2519ktkktk@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 14, 2019

Study Start

November 15, 2018

Primary Completion

November 15, 2020

Study Completion

December 15, 2020

Last Updated

January 14, 2019

Record last verified: 2018-10

Locations

KR(1)