Comparison of Preoperative Frailty Assessment Tools

NCT06889545 | Not Yet Recruiting

• 1 other identifier: 2024-101410-BO-ff
• Study Type: observational
• Target: 584
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Frailty in Older Adults; Frailty/Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Complications in the first 30 days after surgery

  Measured by Clavien-Dindo classification

  30 days

Secondary Outcomes (12)

• Functional state (activities of daily living)

  one, three and six months after surgery

• Postoperative Quality of Recovery

  postoperative day 2

• Muscle loss during hospitalisation

  From date of enrollment, up to 4 weeks after surgery

• Postoperative delirium

  postoperative day 1 to 5

• Length of stay

  from day of surgery, up to 4 weeks after surgery

Study Arms (1)

Older patients

Patients at 70 years and above scheduled for surgery

Other: Assessment of frailty using multiple tools

Interventions

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.

Older patients

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the Medical University Centre Hamburg, Germany

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Centre Hamburg

Hamburg, 22046, Germany

Location

MeSH Terms

Conditions

Frailty; Sarcopenia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Dr. Cynthia Olotu, MD

  University Medical Centre Hamburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Cynthia Olotu, MD

CONTACT

0049 40 7410 52415; c.olotu@uke.de

Study Design

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

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 21, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

DE (1)