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

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05078983
• Other study ID #: 2021/11
• Status: Enrolling by invitation
• Start date: August 17, 2021
• Est. completion date: November 17, 2022

Study information

• Verified date: August 2022
• Source: Gulhane Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 320
• Est. completion date: November 17, 2022
• Est. primary completion date: October 17, 2022
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Muscle Weakness

Intervention

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

Locations

Country	Name	City	State
Turkey	Gulhane training and research hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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