Clinical trial NCT06393647: Relationship Between Albumin/Creatine Ratio, B12, Folate, and Frailty Index
Official title: Relationship Between Albumin/Creatine Ratio, B12, Folate, and Frailty Index in Patients Undergoing Gastrointestinal Malignancy Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty
Keywords: Frailty Scale
Albumin/Creatine Ratio
B12
Folate
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-05-01
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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/Creatine, B12, Folate, Ferritin, Sedimentation Rate, and CRP in patients undergoing gastrointestinal malignancy surgery.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frailty Scale Version 9
timeFrame: one day before surgery
measure: Quality of Life Scale Short Form-36
timeFrame: one day before surgery
Secondary outcomes:
measure: Albumin/Creatine Ratio
timeFrame: one day before surgery
measure: B12 levels
timeFrame: one day before surgery
measure: Folate levels
timeFrame: one day before surgery
Other outcomes:
Locations:
city: Çankaya
country: Turkey
facility: Yusuf
state: Ankara
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle
Study officials:
References:
citation: Kim M, Suzuki T, Kojima N, Yoshida H, Yoshida Y, Hirano H, Won CW, Kim H. Association Between Serum beta2 -Microglobulin Levels and Prevalent and Incident Physical Frailty in Community-Dwelling Older Women. J Am Geriatr Soc. 2017 Apr;65(4):e83-e88. doi: 10.1111/jgs.14733. Epub 2017 Jan 31.
citation: Shamliyan T, Talley KM, Ramakrishnan R, Kane RL. Association of frailty with survival: a systematic literature review. Ageing Res Rev. 2013 Mar;12(2):719-36. doi: 10.1016/j.arr.2012.03.001. Epub 2012 Mar 12.