NCT07440095

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

February 20, 2026

Last Update Submit

April 26, 2026

Conditions

Outcome Measures

Primary Outcomes (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.

    From the date of surgery up to 30 days postoperatively

Secondary Outcomes (4)

  • Modified Frailty Index (mFI-5) Score

    Preoperative assessment (retrospective data from 2022-2025)

  • Preoperative Serum Albumin Level

    Preoperative laboratory values collected retrospectively from 2022-2025.

  • Preoperative Serum Creatinine Level

    Preoperative laboratory values collected retrospectively from 2022-2025.

  • Preoperative Hemoglobin Level

    Preoperative laboratory values collected retrospectively from 2022-2025

Interventions

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.

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 11253156BACKGROUND
  • 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.

    PMID: 20510798BACKGROUND
  • 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.

    PMID: 23395245BACKGROUND

MeSH Terms

Conditions

FrailtyPostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Doctor, Anesthesiology and Reanimation

Study Record Dates

First Submitted

February 20, 2026

First Posted

February 27, 2026

Study Start

March 1, 2026

Primary Completion

April 1, 2026

Study Completion

April 10, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

To protect patient privacy and comply with institutional data protection policies

Locations