NCT06393647

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

April 27, 2024

Last Update Submit

July 30, 2024

Conditions

Keywords

Frailty ScaleAlbumin/Creatine RatioB12Folate

Outcome Measures

Primary Outcomes (2)

  • Frailty Scale Version 9

    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.

    one day before surgery

  • Quality of Life Scale Short Form-36

    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.

    one day before surgery

Secondary Outcomes (3)

  • Albumin/Creatine Ratio

    one day before surgery

  • B12 levels

    one day before surgery

  • Folate levels

    one day before surgery

Study Arms (2)

Frail group

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.

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

Non-frail group

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.

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

Interventions

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, Sedimentation Rate, and CRP in patients undergoing gastrointestinal malignancy surgery.

Frail groupNon-frail group

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yusuf

Çankaya, Ankara, Turkey (Türkiye)

RECRUITING

Ankara Etlik City Hospital

Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28140452BACKGROUND
  • 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.

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 27, 2024

First Posted

May 1, 2024

Study Start

June 15, 2024

Primary Completion

October 15, 2024

Study Completion

November 5, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations