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NCT Number: NCT06889545

Comparison of Preoperative Frailty Assessment Tools

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Assessment of frailty using multiple tools

Other

This is an observational study without any intervention. Frailty is assessed using multiple tools and postoperative outcome is compared.

Primary outcomes

  1. Complications in the first 30 days after surgery

    Time frame: 30 days

    Measured by Clavien-Dindo classification

Secondary outcomes

  1. Functional state (activities of daily living)

    Time frame: one, three and six months after surgery

    Measured using WHO Disability Assessment Schedule 2.0

  2. Postoperative Quality of Recovery

    Time frame: postoperative day 2

    Measured by Quality-of-Recovery-15 questionnaire

  3. Muscle loss during hospitalisation

    Time frame: From date of enrollment, up to 4 weeks after surgery

    measured by bioimpedance prior to admission and before discharge from hospital

  4. Postoperative delirium

    Time frame: postoperative day 1 to 5

    Measured by 3D-Confusion Assessment Method

  5. Length of stay

    Time frame: from day of surgery, up to 4 weeks after surgery

    days spent in hospital after surgery

  6. Discharge destination

    Time frame: up to 4 weeks after surgery

    e.g.:home, nursing home, other hospital

  7. Cognitive state

    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.

  8. Quality-of-Life (QoL)

    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.

  9. Frailty progression measured by LUCAS-FI

    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.

  10. Frailty progression measured by GFI (questionnaire)

    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.

  11. Frailty progression measured by EFS

    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.

  12. 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.

    Time frame: 3 and 6 months after surgery

    Frailty assessment with Risk Analysis Index (index filled by physician, patient telephone interview)

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Cynthia Olotu, MD

CONTACT

[email protected]

0049 40 7410 52415

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Evaluation of a Feasible Frailty Assessment Tool for Preoperative Risk Evaluation of Older Patients

Acronym: PREFAS

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 21, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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