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

NCT05078983 | Unknown

• 1 other identifier: 2021/11
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail Elderly Syndrome; Muscle Weakness

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

HIGH RISK

HIGH RISK MEANS PATIENTS HAVE ASA SCORE OVER 2

Diagnostic Test: CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX)

LOW RISK

LOW RISK MEANS PATIENTS HAVE ASA SCORE BELOW 3

Diagnostic Test: CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX)

Interventions

CGA-FI (COMPREHENSIVE GERIATRIC ASSESMENT - FRAILITY INDEX) DIAGNOSTIC_TEST

GERIATRIC ASSESMENT TEST

HIGH RISK; LOW RISK

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients with advanced stage dementia

Sponsors & Collaborators

• Gulhane Training and Research Hospital: lead

Study Sites (1)

Gulhane training and research hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 15, 2021
• Study Start: August 17, 2021
• Primary Completion: October 17, 2022
• Study Completion: November 17, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

TU (1)