Skip to main content
OpenTrials
Completed

NCT Number: NCT06866678

Frailty Score and Postoperative Morbidity in Colorectal Cancer Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational Data Collection

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative Mortality

    Time frame: 30 days after surgery

    All-cause mortality within 30 days after surgery

  2. Length of Hospital Stay

    Time frame: From surgery to hospital discharge (up to 30 days)

    Total length of postoperative hospital stay (in days)

  3. 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)

  4. Surgical Site Infection

    Time frame: 30 days after surgery

    Incidence of surgical site infections (SSI) within 30 days after surgery

  5. Unplanned Reoperation

    Time frame: 30 days after surgery

    Incidence of unplanned reoperations within 30 days after surgery

  6. Unplanned Readmission

    Time frame: 30 days after discharge

    Incidence of unplanned readmission within 30 days of hospital discharge

  7. Postoperative Delirium

    Time frame: During hospital stay (up to 14 days)

    Incidence of postoperative delirium during hospitalization

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.