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FrailtyNCT07440095

Mortality Predictors in Patients 80+ After Major Abdominal Surgery: Role of Frailty and Physiological Reserve

An observational study of Frailty and Postoperative Complications, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to identify independent risk factors for 30-day mortality in patients aged 80 and over who have undergone major abdominal surgery. While traditional risk scoring systems often focus on chronic disease burden, they may not fully capture the biological decline associated with aging. Read more about this study

Who is it for?
Ages 80 years and older
What is being tested?
Major Abdominal Surgery and Frailty Assessment
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2026to 10 Apr 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: The study population consists of "old-old" patients (aged 80 years and older) who underwent major abdominal surgery at a tertiary oncology center (Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital) between January 2022 and December 2025. This population includes patients who received surgical interventions in the departments of surgical oncology, gynecologic oncology, and urologic oncology. The sample represents a high-risk geriatric group undergoing complex oncological or major abdominal procedures, where frailty and physiological reserve are critical factors for survival.

Who may be able to join

  • Patients aged 80 years and older
  • Underwent major abdominal surgery between January 2022 and December 2025
  • Availability of at least 30 days of postoperative follow-up data
  • Complete medical records available in the hospital information system

Who cannot join

  • Patients under 80 years of age
  • Underwent surgical procedures other than major abdominal surgery
  • Missing or incomplete follow-up data within the first 30 days postoperatively
  • Insufficient data for the assessment of frailty (mFI-5) or physiological reserve parameters (e.g., missing preoperative laboratory values)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea

    Ankara, Yenimahalle, 06200

Other trials in Turkey (Türkiye)

About this study

Official title: Mortality Predictors After Major Abdominal Surgery in Patients Aged 80 and Over: The Role of Frailty and Physiological Reserve

The aim of this study is to identify independent risk factors for 30-day mortality in patients aged 80 and over who have undergone major abdominal surgery. While traditional risk scoring systems often focus on chronic disease burden, they may not fully capture the biological decline associated with aging. This research specifically focuses on the predictive value of "frailty" and "physiological reserve" in determining surgical outcomes for this "old-old" patient population.

In this retrospective cohort study, data from approximately 200 patients treated between 2022 and 2025 will be analyzed. Frailty will be assessed using the Modified Frailty Index (mFI-5), and physiological reserve will be evaluated through preoperative laboratory markers such as albumin, creatinine, and lymphocyte counts. By determining how these factors influence postoperative mortality, the study aims to improve preoperative patient selection, enhance risk communication with families, and provide a basis for protective strategies like prehabilitation.

Read the detailed description

As the global population ages, the "old-old" (aged 80 and over) patient group is increasingly encountered in surgical clinics. Major abdominal surgery in this demographic is categorized as high-risk due to both the severity of surgical trauma and the presence of multiple comorbidities. Traditional risk assessment tools often emphasize chronic disease burden but may fail to reflect the loss of biological resilience inherent in aging. "Frailty" has emerged as a critical parameter in predicting surgical outcomes, representing a state of reduced physiological reserve and increased vulnerability to stressors, independent of chronological age.

This retrospective study is designed to investigate the independent predictors of 30-day mortality in patients aged 80 and older who underwent major abdominal surgery (including gynecologic oncology, surgical oncology, and urologic oncology procedures) at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital.

Methodology and Data Collection:

Patient data from the years 2022, 2023, 2024, and 2025 will be extracted from the hospital's electronic database. The study will include approximately 200 patients who meet the inclusion criteria.

Frailty Assessment: The Modified Frailty Index (mFI-5) will be utilized to evaluate the frailty status of each patient. This index is a validated tool for retrospective studies and includes parameters such as functional status and history of specific comorbidities.

Physiological Reserve: This will be assessed using objective preoperative clinical and laboratory parameters, including serum albumin levels, creatinine, leukocyte/lymphocyte ratios, hemoglobin levels, and the American Society of Anesthesiologists (ASA) physical status score.

Outcome Measure: The primary endpoint is 30-day postoperative mortality. If 30-day follow-up data is not available in the hospital records, patients or their relatives will be contacted via telephone to determine the survival status.

Being tested
Major Abdominal Surgery and Frailty Assessment
Medical subject headings
Frailty, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Major Abdominal Surgery and Frailty AssessmentOther

    Retrospective evaluation of patients aged 80 and over who underwent major abdominal surgery (including surgical oncology, gynecologic oncology, and urologic oncology). The study involves the assessment of preoperative frailty using the Modified Frailty Index (mFI-5) and the analysis of physiological reserve through laboratory markers (albumin, creatinine, lymphocyte count, hemoglobin). The primary focus is to determine the impact of these factors on 30-day postoperative mortality.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-Day Postoperative Mortality

    The occurrence of death from any cause within 30 days following the major abdominal surgical procedure. This will be assessed using hospital electronic records and, if necessary, through telephone follow-ups with patients or their relatives.

    Measured: From the date of surgery up to 30 days postoperatively

Secondary outcomes (4)

  1. Modified Frailty Index (mFI-5) Score

    Assessment of patients' frailty status using the Modified Frailty Index (mFI-5). The mFI-5 consists of 5 items: history of hypertension, diabetes mellitus, congestive heart failure, chronic obstructive pulmonary disease, and functional status. Each item is assigned 1 point if present. The total score ranges from 0 to 5, where 0 represents "not frail" and 5 represents "severely frail." Higher scores indicate a higher degree of frailty and a worse clinical outcome

    Measured: Preoperative assessment (retrospective data from 2022-2025)

  2. Preoperative Serum Albumin Level

    Evaluation of preoperative serum albumin levels (measured in g/dL) as an indicator of nutritional status and physiological reserve.

    Measured: Preoperative laboratory values collected retrospectively from 2022-2025.

  3. Preoperative Serum Creatinine Level

    Evaluation of preoperative serum creatinine levels (measured in mg/dL) to assess renal function as part of the physiological reserve

    Measured: Preoperative laboratory values collected retrospectively from 2022-2025.

  4. Preoperative Hemoglobin Level

    Evaluation of preoperative hemoglobin levels (measured in g/dL) to assess the oxygen-carrying capacity and physiological reserve.

    Measured: Preoperative laboratory values collected retrospectively from 2022-2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start1 Mar 2026
  3. Primary completion1 Apr 2026
  4. Study completion10 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07440095
Sponsor's protocol ID
2026-02/31
Status last verified
Apr 2026
First submitted
20 Feb 2026
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To protect patient privacy and comply with institutional data protection policies

Publications

  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PubMed 11253156

  • Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.

    PubMed 20510798

  • Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.

    PubMed 23395245

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty and Postoperative Complications, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-Day Postoperative Mortality (time frame: From the date of surgery up to 30 days postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07440095, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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