University Medical Centre Hamburg
Hamburg, 22046, Germany
Location status: Recruiting
NCT Number: NCT06889545
Frailty is a significant risk factor for postoperative complications and functional decline. Preoperative assessment of frailty is therefore recommended in all older adults. However, despite the availability of many frailty tools, few have been tested in the preoperative setting and there is little comparison of their predictive value in identifying patients at risk. The aim of this study is to investigate which of the following instruments for determining frailty has the highest predictive power with regard to the occurrence of postoperative complications: Risk Analysis Index, Clinical Frailty Scale, the Groningen Frailty Indicator, the Edmonton Frail Scale and the LUCAS-FI. The aim of this research project is to identify a suitable frailty instrument for preoperative risk stratification of older patients during the premedication visit.
Interested in participating?
Request Info70 year and older
All sexes
Observational
Hamburg, 22046, Germany
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is an observational study without any intervention. Frailty is assessed using multiple tools and postoperative outcome is compared.
Time frame: 30 days
Measured by Clavien-Dindo classification
Time frame: one, three and six months after surgery
Measured using WHO Disability Assessment Schedule 2.0
Time frame: postoperative day 2
Measured by Quality-of-Recovery-15 questionnaire
Time frame: From date of enrollment, up to 4 weeks after surgery
measured by bioimpedance prior to admission and before discharge from hospital
Time frame: postoperative day 1 to 5
Measured by 3D-Confusion Assessment Method
Time frame: from day of surgery, up to 4 weeks after surgery
days spent in hospital after surgery
Time frame: up to 4 weeks after surgery
e.g.:home, nursing home, other hospital
Time frame: 3 and 6 months after surgery
Using 5-Minute Montreal Cognitive Assessment (telephone-MOCA). A maximum of 15 points and a minumum of 0 points can be archieved; a higher score indicates better cognitive performance.
Time frame: 3 and 6 months after surgery
Measured by WHO-Quality of Life in older adults (WHOQOL-OLD) questionnaire. The WHOQOL-OLD is evaluated by calculating scores for its six facets and summing them, with higher scores indicating a better perceived quality of life.
Time frame: 3 and 6 months after surgery
Frailty assessment with Longitudinal Urban Cohort Aging Study Functional Index (LUCAS-FI)-questionnaire (telephone interview) The LUCAS-FI is evaluated by integrating both risk factors and protective resources, with the balance between them determining the degree of frailty.
Time frame: 3 and 6 months after surgery
frailty assessment with Groningen Frailty Indicator (GFI) questionnaire (telephone interview).
The GFI is evaluated by summing its item responses, with higher scores indicating a higher degree of frailty.
Time frame: 3 and 6 months after surgery
Frailty assessment by Edmonton Frail Scale (EFS), (score filled by physician, patient telephone interview).
1 to 10 points can be archieved, more points indicate a greater level of frailty.
Time frame: 3 and 6 months after surgery
Frailty assessment with Risk Analysis Index (index filled by physician, patient telephone interview)
Contact information is provided by the study sponsor or research team.
Universitätsklinikum Hamburg-Eppendorf
Other
Evaluation of a Feasible Frailty Assessment Tool for Preoperative Risk Evaluation of Older Patients
Acronym: PREFAS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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