Comparison of Preoperative Frailty Assessment Tools

Not yet recruiting

• Conditions: Frailty; Frailty in Older Adults; Frailty/Sarcopenia

• Registration Number: NCT06889545
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-23
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-16
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-30
• Last Update Posted: 2025-04-03
• Study Start: 2025-04-15
• Primary Completion: 2027-04-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 584

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complications in the first 30 days after surgery	30 days	Measured by Clavien-Dindo classification

Secondary Outcome Measures

Name	Time	Method
Functional state (activities of daily living)	one, three and six months after surgery	Measured using WHO Disability Assessment Schedule 2.0
Postoperative Quality of Recovery	postoperative day 2	Measured by Quality-of-Recovery-15 questionnaire
Muscle loss during hospitalisation	From date of enrollment, up to 4 weeks after surgery	measured by bioimpedance prior to admission and before discharge from hospital
Postoperative delirium	postoperative day 1 to 5	Measured by 3D-Confusion Assessment Method
Length of stay	from day of surgery, up to 4 weeks after surgery	days spent in hospital after surgery
Discharge destination	up to 4 weeks after surgery	e.g.:home, nursing home, other hospital
Cognitive state	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.
Quality-of-Life (QoL)	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.
Frailty progression measured by LUCAS-FI	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.
Frailty progression measured by GFI (questionnaire)	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.
Frailty progression measured by EFS	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.
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.	3 and 6 months after surgery	Frailty assessment with Risk Analysis Index (index filled by physician, patient telephone interview)

Trial Locations

Locations (1)

University Medical Centre Hamburg; 🇩🇪 Hamburg, Germany