NCT03199859

Brief Summary

  1. 1.Observe the characteristics of delirium patients, searching for early diagnostic methods or finding risk factors
  2. 2.Design a guideline for delirium, diagnosis or treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

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

Study Start

First participant enrolled

May 17, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

2.5 years

First QC Date

June 22, 2017

Last Update Submit

September 20, 2019

Conditions

Delirium

Keywords

gastric cancerpostoperativesubsyndromal deliriumquality of life

Outcome Measures

Primary Outcomes (1)

  • Delirium Rating Scale-98

    Delirium rating tool, score of 8 for subsyndromal delirium, 15 for delirium

    Till 1 year after surgery

Secondary Outcomes (1)

  • Functional assessment of cancer therapy - gastric cancer

    Till 1 year after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the gastric cancer department of general surgery at Seoul National University Hospital due for surgical resection were included.

You may qualify if:

  • Curable malignant gastric cancer

You may not qualify if:

  • Gastrointestinal stromal tumor
  • Uncurable cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 16801, South Korea

Location

MeSH Terms

Conditions

DeliriumStomach Neoplasms

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 22, 2017

First Posted

June 27, 2017

Study Start

May 17, 2016

Primary Completion

October 31, 2018

Study Completion

December 31, 2018

Last Updated

September 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)