Frailty Score and Postoperative Morbidity in Colorectal Cancer Surgery

April 26, 2026 updated by: Mustafa Kemal ŞAHİN, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Can the Frailty Score Independently Predict Surgical Risk and Postoperative Morbidity in Patients With Colorectal Cancer?

This prospective observational study aims to evaluate the independent predictive value of the Edmonton Frailty Index (EFI) in estimating postoperative morbidity among older patients undergoing elective colorectal cancer surgery. Frailty, characterized by a decline in physiological reserves and increased vulnerability to stressors, has been recognized as a stronger predictor of adverse postoperative outcomes than chronological age alone. While the relationship between frailty and surgical outcomes has been extensively investigated in general surgical populations, data specifically focusing on patients with colorectal cancer remain limited.

In this study, patients aged 65 years and older scheduled for elective colorectal cancer surgery will undergo preoperative frailty assessment using the validated Edmonton Frailty Index (EFI). Postoperative complications, length of intensive care unit (ICU) stay, total hospital stay, and 30-day adverse outcomes, including mortality, myocardial infarction, pulmonary embolism, sepsis, and the need for reoperation, will be recorded and analyzed.

The primary objective is to determine whether frailty, as measured by the Edmonton Frailty Index, serves as an independent predictor of postoperative morbidity in this specific patient population. Secondary objectives include exploring associations between frailty and intraoperative variables such as blood loss, fluid administration, and vasopressor requirements.

By addressing this gap, the study aims to contribute to the growing body of evidence supporting the routine incorporation of frailty assessment into preoperative risk stratification protocols for older patients with colorectal cancer. The ultimate goal is to enhance perioperative risk assessment, optimize perioperative care, and improve patient outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective, observational study aims to evaluate whether the Frailty Risk Index (FRI) can independently predict postoperative morbidity in patients undergoing elective surgery for colorectal cancer. Frailty is a clinical syndrome characterized by decreased physiological reserve and increased vulnerability to stressors, particularly in elderly populations. Recent studies have demonstrated that frailty is a better predictor of adverse postoperative outcomes than chronological age, especially among cancer patients and the elderly surgical population.

The study will be conducted at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. Data will be collected from anesthesia records of patients who undergo elective colorectal cancer surgery in the General Surgery and Surgical Oncology clinics. The sample size was calculated based on the hypothesis that patients with a high Frailty Risk Score will have increased rates of postoperative morbidity. A minimum of 69 patients is required to achieve 90% power with a type I error rate of 0.05 and a medium effect size (0.5). To account for potential dropouts and missing data, a total of 80 patients will be included.

The primary objective is to assess the independent predictive value of the Frailty Risk Index for postoperative clinical outcomes in colorectal cancer patients. Secondary objectives include comparing postoperative complication rates, intensive care unit admissions, length of hospital stay, and 30-day adverse events (such as mortality, myocardial infarction, pulmonary embolism, and sepsis) between frail and non-frail patients.

Patients aged 65 years and older who are scheduled for elective colorectal cancer surgery and can be evaluated preoperatively with the FRI will be included. Exclusion criteria are emergency surgery, severe comorbidities that preclude surgery, neurological or psychiatric disorders that impair consciousness assessment, and inability or unwillingness to provide informed consent.

The Frailty Risk Index will be assessed based on five criteria: unintentional weight loss, self-reported exhaustion, weakness (reduced grip strength), slow walking speed, and low physical activity. Patients meeting three or more criteria will be classified as frail.

Data collection will include preoperative variables (age, sex, ASA score, comorbidities, diagnosis, metastasis status), intraoperative variables (anesthesia management, blood loss, fluid and blood product administration, vasopressor requirement), and postoperative outcomes (complications within 24 hours, ICU admission and stay, hospital length of stay, and adverse events within 30 days).

Statistical analysis will involve independent t-tests and chi-square tests for group comparisons, and multivariate logistic regression to assess the independent effect of the Frailty Risk Index on postoperative outcomes. A p-value of <0.05 will be considered statistically significant.

This study aims to fill a gap in the literature regarding the predictive value of frailty assessment in colorectal cancer surgery and to contribute to improved risk stratification and perioperative management in this patient population.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye), 06200
        • Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This is a prospective, observational study to be conducted between February 20, 2025, and June 1, 2025, in the General Surgery and Surgical Oncology departments of our hospital. The study population will consist of patients aged 18 years and older undergoing elective colorectal cancer surgery. Data will be collected from preoperative frailty assessments using the Edmonton Frailty Scale (EFS), anesthesia records, and postoperative follow-up documents

Description

Inclusion Criteria:

  • Patients aged 65 years and older
  • Patients undergoing surgery for colorectal cancer
  • Patients scheduled for elective (non-emergency) surgery
  • Individuals eligible for preoperative frailty assessment using the Edmonton Frailty Scale (EFS)
  • Patients who can be followed for at least 30 days postoperatively
  • Patients able to provide informed consent

Exclusion Criteria:

  • Patients requiring emergency surgery
  • Neurological or psychiatric disorders that prevent the assessment of consciousness level
  • Severe comorbidities (Patients with extremely high surgical risk due to severe cardiovascular, respiratory, or other systemic diseases)
  • Patients who do not or cannot provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Frail
Patients aged 65 years and older undergoing elective colorectal cancer surgery who meet three or more criteria on the Frailty Risk Index (FRI), and are classified as frail. These patients are expected to have increased vulnerability to postoperative complications.
Procedure: Observational Data Collection
No intervention will be performed as part of this study. This is an observational study; all patients will receive standard perioperative care according to current clinical practice. The study will only observe and record data related to frailty status and postoperative outcomes in patients undergoing elective colorectal cancer surgery. No experimental procedures, drugs, or additional interventions will be administered.
Non-Frail
Patients aged 65 years and older undergoing elective colorectal cancer surgery who meet fewer than three criteria on the Frailty Risk Index (FRI), and are classified as non-frail. These patients are expected to have lower risk for postoperative complications compared to the frail group.
Procedure: Observational Data Collection
No intervention will be performed as part of this study. This is an observational study; all patients will receive standard perioperative care according to current clinical practice. The study will only observe and record data related to frailty status and postoperative outcomes in patients undergoing elective colorectal cancer surgery. No experimental procedures, drugs, or additional interventions will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complication Rate Postoperative Complication Rate (Clavien-Dindo ≥ Grade II)
Time Frame: 30 days after surgery
The primary outcome is the incidence of postoperative complications within 30 days after surgery, classified according to the Clavien-Dindo Classification System (Grade II and above). The relationship between preoperative frailty status, measured using the Edmonton Frailty Scale (EFS), and the development of postoperative complications will be assessed.
30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Mortality
Time Frame: 30 days after surgery
All-cause mortality within 30 days after surgery
30 days after surgery
Length of Hospital Stay
Time Frame: From surgery to hospital discharge (up to 30 days)
Total length of postoperative hospital stay (in days)
From surgery to hospital discharge (up to 30 days)
ICU Admission and Length of Stay
Time Frame: From surgery to hospital discharge (up to 30 days)
Requirement for ICU admission and duration of ICU stay (in days)
From surgery to hospital discharge (up to 30 days)
Surgical Site Infection
Time Frame: 30 days after surgery
Incidence of surgical site infections (SSI) within 30 days after surgery
30 days after surgery
Unplanned Reoperation
Time Frame: 30 days after surgery
Incidence of unplanned reoperations within 30 days after surgery
30 days after surgery
Unplanned Readmission
Time Frame: 30 days after discharge
Incidence of unplanned readmission within 30 days of hospital discharge
30 days after discharge
Postoperative Delirium
Time Frame: During hospital stay (up to 14 days)
Incidence of postoperative delirium during hospitalization
During hospital stay (up to 14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Investigators

  • Principal Investigator: Mustafa Kemal SAHIN, Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2025

Primary Completion (Actual)

September 10, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 26, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-02/28

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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