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Early Diagnosis and Treatment Standardization of Delirium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03199859
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Bong-Jin Hahm, Seoul National University Hospital

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

Condition or disease
Delirium

Detailed Description:

The study is consisted of two parts; First, observational study of gastric cancer patients admitted to hospital, diagnosing the presence of delirium or subsyndromal delirium and collecting patient data, including assessment, self-report surveys, and electronic medical records.

Second, Designing a guideline for treating delirium patients in Korea using the study data and reviewing other studies, guidelines.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Early Diagnosis and Treatment Standardization of Delirium
Actual Study Start Date : May 17, 2016
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium




Primary Outcome Measures :
  1. Delirium Rating Scale-98 [ Time Frame: Till 1 year after surgery ]
    Delirium rating tool, score of 8 for subsyndromal delirium, 15 for delirium


Secondary Outcome Measures :
  1. Functional assessment of cancer therapy - gastric cancer [ Time Frame: Till 1 year after surgery ]
    Quality of life measuring tool for gastric cancer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients admitted to the gastric cancer department of general surgery at Seoul National University Hospital due for surgical resection were included.
Criteria

Inclusion Criteria:

  • Curable malignant gastric cancer

Exclusion Criteria:

  • Gastrointestinal stromal tumor
  • Uncurable cancer

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): NCT03199859


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 16801
Sponsors and Collaborators
Seoul National University Hospital

Additional Information:

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Responsible Party: Bong-Jin Hahm, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03199859     History of Changes
Other Study ID Numbers: 072016105
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bong-Jin Hahm, Seoul National University Hospital:
gastric cancer
postoperative
subsyndromal delirium
quality of life
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders