- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07440095
Mortality Predictors in Patients 80+ After Major Abdominal Surgery: Role of Frailty and Physiological Reserve
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Yenimahalle
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Ankara, Yenimahalle, Turkey (Türkiye), 06200
- Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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30-Day Postoperative Mortality
Time Frame: From the date of surgery up to 30 days postoperatively
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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.
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From the date of surgery up to 30 days postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Frailty Index (mFI-5) Score
Time Frame: Preoperative assessment (retrospective data from 2022-2025)
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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
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Preoperative assessment (retrospective data from 2022-2025)
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Preoperative Serum Albumin Level
Time Frame: Preoperative laboratory values collected retrospectively from 2022-2025.
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Evaluation of preoperative serum albumin levels (measured in g/dL) as an indicator of nutritional status and physiological reserve.
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Preoperative laboratory values collected retrospectively from 2022-2025.
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Preoperative Serum Creatinine Level
Time Frame: Preoperative laboratory values collected retrospectively from 2022-2025.
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Evaluation of preoperative serum creatinine levels (measured in mg/dL) to assess renal function as part of the physiological reserve
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Preoperative laboratory values collected retrospectively from 2022-2025.
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Preoperative Hemoglobin Level
Time Frame: Preoperative laboratory values collected retrospectively from 2022-2025
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Evaluation of preoperative hemoglobin levels (measured in g/dL) to assess the oxygen-carrying capacity and physiological reserve.
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Preoperative laboratory values collected retrospectively from 2022-2025
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-02/31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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