Clinical trial NCT06889545: Comparison of Preoperative Frailty Assessment Tools
Official title: Evaluation of a Feasible Frailty Assessment Tool for Preoperative Risk Evaluation of Older Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Frailty
Frailty in Older Adults
Frailty/Sarcopenia
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 584
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the Medical University Centre Hamburg, Germany

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 70 years and older
* scheduled surgery
* estimated time of surgery 120 Minutes or more

Exclusion Criteria:

* insufficient German language skills (for cognitive testing)
* mental retardation
* relevant psychiatric disorder (not allowing for cognitive testing)

Primary outcomes:
measure: Complications in the first 30 days after surgery
timeFrame: 30 days
Secondary outcomes:
measure: Functional state (activities of daily living)
timeFrame: one, three and six months after surgery
measure: Postoperative Quality of Recovery
timeFrame: postoperative day 2
measure: Muscle loss during hospitalisation
timeFrame: From date of enrollment, up to 4 weeks after surgery
measure: Postoperative delirium
timeFrame: postoperative day 1 to 5
measure: Length of stay
timeFrame: from day of surgery, up to 4 weeks after surgery
measure: Discharge destination
timeFrame: up to 4 weeks after surgery
measure: Cognitive state
timeFrame: 3 and 6 months after surgery
measure: Quality-of-Life (QoL)
timeFrame: 3 and 6 months after surgery
measure: Frailty progression measured by LUCAS-FI
timeFrame: 3 and 6 months after surgery
measure: Frailty progression measured by GFI (questionnaire)
timeFrame: 3 and 6 months after surgery
measure: Frailty progression measured by EFS
timeFrame: 3 and 6 months after surgery
measure: Frailty progression by RAI measurement. The Risk Analysis Index (RAI) is evaluated by summing weighted risk factors and protective variables, with higher scores indicating greater patient vulnerability.
timeFrame: 3 and 6 months after surgery
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Centre Hamburg
Study officials:
affiliation: University Medical Centre Hamburg
name: Dr. Cynthia Olotu, MD
role: PRINCIPAL_INVESTIGATOR
References: