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

• Conditions: Frail Elderly Syndrome; Muscle Weakness
• Interventions: Diagnostic Test: CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX)

• Registration Number: NCT05078983
• Lead Sponsor: Gulhane Training and Research Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-17
• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-10-02
• Study First Posted: 2021-10-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-04
• Primary Completion: 2022-10-17
• Study Completion: 2022-11-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LOW RISK	CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX)	LOW RISK MEANS PATIENTS HAVE ASA SCORE BELOW 3
HIGH RISK	CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX)	HIGH RISK MEANS PATIENTS HAVE ASA SCORE OVER 2

Primary Outcome Measures

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

Trial Locations

Locations (1)

Gulhane training and research hospital; 🇹🇷 Ankara, Turkey