- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06393647
Relationship Between Albumin/Creatine Ratio, B12, Folate, and Frailty Index
Relationship Between Albumin/Creatine Ratio, B12, Folate, and Frailty Index in Patients Undergoing Gastrointestinal Malignancy Surgery
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) 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 Overview
Status
Conditions
Intervention / Treatment
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.
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 form (Frailty Scale Version 9) 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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yusuf Ozguner
- Phone Number: 05427150725
- Email: y.ozguner@hotmail.com
Study Locations
-
-
Ankara
-
Çankaya, Ankara, Turkey (Türkiye)
- Recruiting
- Yusuf
-
Contact:
- Yusuf Ozguner
- Phone Number: 05427150725
- Email: y.ozguner@hotmail.com
-
-
Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle
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Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, Turkey (Türkiye), 06170
- Recruiting
- Ankara Etlik City Hospital
-
Contact:
- Yusuf Ozguner
- Phone Number: +903127970000
- Email: etliksh.iletisim@saglik.gov.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
In our study, we aim to investigate the relationship between frailty status assessed using frailty scale form (Frailty Scale Version 9) and preoperative levels of Albumin/Creatine, B12, Folate, Ferritin, Sedimentation Rate, and CRP in patients undergoing gastrointestinal malignancy surgery.
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: CASE_ONLY
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Undergoing gastrointestinal malignancy surgery
In our study, we aim to investigate the relationship between frailty status assessed using frailty scale form (Frailty Scale Version 9) and preoperative levels of Albumin/Creatinine, B12, Folate, Hemogram in patients undergoing gastrointestinal malignancy 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. |
In our study, we aim to investigate the relationship between frailty status assessed using frailty scale form (Frailty Scale Version 9) and preoperative levels of Albumin/Creatinine, B12, Folate, Ferritin, Sedimentation Rate, and CRP in patients undergoing gastrointestinal malignancy surgery. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association between preoperative Clinical Frailty Scale (CFS) score and serum albumin-to-creatinine ratio
Time Frame: 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.(Association between preoperative Clinical Frailty Scale (CFS) score and serum albumin-to-creatinine ratio.) |
one day before surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association between preoperative Clinical Frailty Scale (CFS) score and B12 levels
Time Frame: one day before surgery
|
B12 concentration will be measured |
one day before surgery
|
|
Association between preoperative Clinical Frailty Scale (CFS) score and Folate levels
Time Frame: one day before surgery
|
Folate concentration will be measured |
one day before surgery
|
|
Association between preoperative Clinical Frailty Scale (CFS) score and iron levels
Time Frame: one day before surgery
|
Serum iron concentration will be measured. |
one day before surgery
|
|
Association between preoperative Clinical Frailty Scale (CFS) score and Hemoglobin/RDW ratio.
Time Frame: one day before surgery
|
Hemoglobin/RDW ratio will be measured. |
one day before surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yusuf Ozguner, Ankara Etlik City Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AnkaraEtlikYusufOzguner007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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