NCT04168268

Brief Summary

To assess self-reported cognitive function and health-related quality of life in patients with and without early postoperative delirium

Trial Health

87
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 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

Study Start

First participant enrolled

November 28, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

November 16, 2019

Last Update Submit

November 16, 2019

Conditions

DeliriumNeurocognitive Disorders

Outcome Measures

Primary Outcomes (1)

  • Self-reported cognitive failures

    Cognitive Failures Questionnaire

    three months

Secondary Outcomes (1)

  • Health-related quality of life

    three months

Eligibility Criteria

Age60 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for elective radical prostatectomy for prostate cancer at a high-volume prostate cancer center were screened on the day before surgery.

You may qualify if:

  • elective radical prostatectomy
  • \>60 years
  • fluent in German

You may not qualify if:

  • preexisting cognitive impairment
  • cerebrovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

  • Kainz E, Stuff K, Kahl U, Wiessner C, Yu Y, von Breunig F, Nitzschke R, Haese A, Graefen M, Fischer M. Impact of postanesthesia care unit delirium on self-reported cognitive function and perceived health status: a prospective observational cohort study. Qual Life Res. 2022 Aug;31(8):2397-2410. doi: 10.1007/s11136-022-03087-1. Epub 2022 Jan 27.

    PMID: 35084649DERIVED

MeSH Terms

Conditions

DeliriumNeurocognitive Disorders

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

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

Study Record Dates

First Submitted

November 16, 2019

First Posted

November 19, 2019

Study Start

November 28, 2017

Primary Completion

December 11, 2018

Study Completion

December 11, 2018

Last Updated

November 19, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)