Investigation of Relation With Preoperative Fragility and ASA Score in Elderly Patients

Frailty is a term specific to the geriatric period. It is used to describe weak, unstable, frail patients and partially expresses the frailty of the elderly patient. Once the frailty process begins, the risk of loss of mobility, dependency and mortality increases.

Frailty is an important predictor of adverse outcomes after surgery. According to studies conducted in various surgical situations, fragility is a major risk factor for morbidity, mortality and longer hospital stay. According to the available data, frailty has a sufficient basis for determining the risks of patients before surgery, developing preventive methods and making personal treatment decisions. As the frailty index increased, it was observed that the duration of postoperative hospital stay was associated with the need for intensive care, postoperative complications, and the rate of re-admissions within 30 days.

ASA (American Society of Anesthesiologists) classification is widely used in order to evaluate the physical condition preoperatively in geriatric individuals with multiple comorbidities. Considering the fragility variable while creating the ASA score in the preoperative period may be useful in determining the follow-up strategy during the operation and postoperative period. For example, a patient who is evaluated as ASA 2 because he has no problems other than simple 1-2 comorbid conditions, involuntary weakening of 5% in the last 1 year (not easily noticed), weakness (can only be detected with a dynamometer) and cessation of going out of the house (can only be understood when asked privately). ) can be categorized as at risk at ASA level 3-4, as it is understood to be fragile.

The aim of this project is to examine the frequency of frailty in elderly individuals who will be operated on, and to examine the relationship between frailty and ASA score using the anthropometry and comorbidity differences between frail preoperative patients and those who do not.

Study Overview

• Status: Enrolling by invitation
• Conditions: Muscle Weakness; Frail Elderly Syndrome
• Intervention / Treatment: Diagnostic test: CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX)

• Study Type: Observational
• Enrollment (Anticipated): 320

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Gulhane Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients over the age of 65 who were admitted to the general surgery service for surgery and then operated.

Description

Inclusion Criteria:

- Patients over the age of 65 who were admitted to the general surgery service for surgery and then operated.

Exclusion Criteria:

-Patients with advanced stage dementia

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HIGH RISK; HIGH RISK MEANS PATIENTS HAVE ASA SCORE OVER 2	Diagnostic test: CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX); GERIATRIC ASSESMENT TEST
LOW RISK; LOW RISK MEANS PATIENTS HAVE ASA SCORE BELOW 3	Diagnostic test: CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX); GERIATRIC ASSESMENT TEST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DEATH RATE	PROPORTION OF PATIENTS WHO DIED TO ALL PATIENTS	AT 1 MONTH AND 3 MONTH AFTER OPERATION
LENGTH OF HOSPITAL STAY	NUMBER OF NIGHTS THE PATIENT NEEDS TO STAY IN HOSPITAL	AT 1 MONTH
DELIRIUM RATE	THE RATIO OF THE NUMBER OF PATIENTS IN DELIRIUM TO THE TOTAL NUMBER OF PATIENTS AFTER OPERATION	AT 1 MONTH
INTENSIVE CARE RATE	THE RATIO OF THE NUMBER OF PATIENTS NEED INTENSIVE CARE AFTER OPERATION TO TOTAL NUMBER OF PATIENTS	AT 1 MONTH

Collaborators and Investigators

• Sponsor: Gulhane Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2021
• Primary Completion (Anticipated): October 17, 2022
• Study Completion (Anticipated): November 17, 2022

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 2, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: 2021/11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No