Relationship Between Albumin/Creatine Ratio, B12, Folate, and Frailty Index

Recruiting

• Conditions: Frailty
• Interventions: Other: Frailty scale forms (Frailty Scale Version 9, Quality of Life Scale Short Form-36)

• Registration Number: NCT06393647
• Lead Sponsor: Ankara Etlik City Hospital

Brief Summary

In the literature, the relationship between frailty and various blood tests such as beta-2 microglobulin, CRP, procalcitonin, vitamin D, IL-1, and IL-6 has been investigated (2). In our study, the investigators aim to investigate the relationship between frailty status assessed using frailty scale forms (Frailty Scale Version 9, Quality of Life Scale Short Form-36) and preoperative levels of Albumin/Creatinine, B12, Folate, Ferritin, hemogram, Sedimentation Rate, and CRP in patients undergoing gastrointestinal malignancy surgery. By identifying the relationship among these parameters, the investigators believe that modifiable factors contributing to frailty in patients at risk can be addressed through appropriate interventions.

Detailed Description

Frailty is a condition associated with a decline in physiological performance. Patients are categorized as healthy, pre-frail, or frail based on physiological and functional characteristics. Frailty is known to be influenced by various lifestyle factors such as socioeconomic status, psychological factors, diet, exercise, and genetic predisposition. With aging, there is an increase in cognitive and physical dysfunction, which correlates with an increase in frailty. Along with frailty, geriatric symptoms, mortality, and other negative health outcomes also increase in the elderly population. Therefore, early detection of frailty is crucial to implementing lifestyle changes aimed at improving cognitive and physical status. Various assessment scales are used to evaluate frailty, such as the Frailty Scale Version 9, Quality of Life Scale Short Form-36, and Modified 5-item frailty index (mFI-5) In the literature, the relationship between frailty and various blood tests such as beta-2 microglobulin, CRP, procalcitonin, vitamin D, IL-1, and IL-6 has been investigated (2). In our study, the investigators aim to investigate the relationship between frailty status assessed using frailty scale forms (Frailty Scale Version 9, Quality of Life Scale Short Form-36) and preoperative levels of Albumin/Creatinine, B12, Folate, Ferritin,hemogram, Sedimentation Rate, and CRP in patients undergoing gastrointestinal malignancy surgery. By identifying the relationship among these parameters, the investigators believe that modifiable factors contributing to frailty in patients at risk can be addressed through appropriate interventions.

Study Timeline

• Study First Submitted: 2024-04-27
• Study First Submitted QC: 2024-04-27
• Study First Posted: 2024-05-01
• Study Start: 2024-06-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2024-10-15
• Study Completion: 2024-11-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients who are over 65 years old.
• Patients classified under ASA (American Society of Anesthesiologists) risk groups I, II, and III.
• Patients with gastrointestinal malignancy undergoing surgery

Exclusion Criteria

• Patients who are under 65 years old.
• Patients with an ASA score of IV or higher.
• Patients who refuse to participate in the study.
• Patients undergoing emergency surgeries will be excluded from the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Frail group	Frailty scale forms (Frailty Scale Version 9, Quality of Life Scale Short Form-36)	In our study, we aim to investigate the relationship between frailty status assessed using frailty scale forms (Frailty Scale Version 9, Quality of Life Scale Short Form-36) and preoperative levels of Albumin/Creatinine, B12, Folate, Ferritin, Hemogram, Sedimentation Rate, and CRP in patients undergoing gastrointestinal malignancy surgery.
Non-frail group	Frailty scale forms (Frailty Scale Version 9, Quality of Life Scale Short Form-36)	In our study, we aim to investigate the relationship between frailty status assessed using frailty scale forms (Frailty Scale Version 9, Quality of Life Scale Short Form-36) and preoperative levels of Albumin/Creatinine, B12, Folate, Ferritin, Hemogram, Sedimentation Rate, and CRP in patients undergoing gastrointestinal malignancy surgery.

Primary Outcome Measures

Name	Time	Method
Quality of Life Scale Short Form-36	one day before surgery	SF-36 is a scale to be used to evaluate quality of life.In this scoring, scoring is between 0-100. Increasing scores are considered as positive health status.
Frailty Scale Version 9	one day before surgery	Patients' frailty status will be assessed using the Frailty Scale Version 9.There are scores between 1 and 9 on this scale. Patients with a score of 4 or above are defined as fraile.

Secondary Outcome Measures

Name	Time	Method
B12 levels	one day before surgery	B12 concentration will be measured
Albumin/Creatine Ratio	one day before surgery	The ratio of albumin and creatinine to each other will be measured.
Folate levels	one day before surgery	Folate concentration will be measured

Trial Locations

Locations (2)

Yusuf; 🇹🇷 Çankaya, Ankara, Turkey

Ankara Etlik City Hospital; 🇹🇷 Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, Turkey