Clinical trial NCT06866678: Frailty Score and Postoperative Morbidity in Colorectal Cancer Surgery
Official title: Can the Frailty Score Independently Predict Surgical Risk and Postoperative Morbidity in Patients With Colorectal Cancer?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Complications
Colorectal Cancer
Frailty
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Complication Rate (Clavien-Dindo ≥ Grade II) Postoperative Complication Rate (Clavien-Dindo ≥ Grade II)
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Postoperative Mortality
timeFrame: 30 days after surgery
measure: Length of Hospital Stay
timeFrame: From surgery to hospital discharge (up to 30 days)
measure: ICU Admission and Length of Stay
timeFrame: From surgery to hospital discharge (up to 30 days)
measure: Surgical Site Infection
timeFrame: 30 days after surgery
measure: Unplanned Reoperation
timeFrame: 30 days after surgery
measure: Unplanned Readmission
timeFrame: 30 days after discharge
measure: Functional Decline
timeFrame: Baseline to 30 days after surgery
measure: Postoperative Delirium
timeFrame: During hospital stay (up to 14 days)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea
state: Yenimahalle
Study officials:
affiliation: Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation
name: Mustafa Kemal SAHIN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmucker AM, Hupert N, Mandl LA. The Impact of Frailty on Short-Term Outcomes After Elective Hip and Knee Arthroplasty in Older Adults: A Systematic Review. Geriatr Orthop Surg Rehabil. 2019 May 6;10:2151459319835109. doi: 10.1177/2151459319835109. eCollection 2019.
citation: Giger AW, Ditzel HM, Ewertz M, Ditzel H, Jorgensen TL, Pfeiffer P, Lund C, Ryg J. Effect of comprehensive geriatric assessment on hospitalizations in older adults with frailty initiating curatively intended oncologic treatment: The PROGNOSIS-RCT study. J Geriatr Oncol. 2024 Sep;15(7):101821. doi: 10.1016/j.jgo.2024.101821. Epub 2024 Jul 20.
citation: Aucoin SD, Hao M, Sohi R, Shaw J, Bentov I, Walker D, McIsaac DI. Accuracy and Feasibility of Clinically Applied Frailty Instruments before Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2020 Jul;133(1):78-95. doi: 10.1097/ALN.0000000000003257.
citation: Elsamadicy AA, Freedman IG, Koo AB, David WB, Reeves BC, Havlik J, Pennington Z, Kolb L, Shin JH, Sciubba DM. Modified-frailty index does not independently predict complications, hospital length of stay or 30-day readmission rates following posterior lumbar decompression and fusion for spondylolisthesis. Spine J. 2021 Nov;21(11):1812-1821. doi: 10.1016/j.spinee.2021.05.011. Epub 2021 May 16.
citation: Cook MJ, Lunt M, Ashcroft DM, Board T, O'Neill TW. The impact of frailty on patient-reported outcomes following hip and knee arthroplasty. Age Ageing. 2022 Dec 5;51(12):afac288. doi: 10.1093/ageing/afac288.
citation: Panayi AC, Orkaby AR, Sakthivel D, Endo Y, Varon D, Roh D, Orgill DP, Neppl RL, Javedan H, Bhasin S, Sinha I. Impact of frailty on outcomes in surgical patients: A systematic review and meta-analysis. Am J Surg. 2019 Aug;218(2):393-400. doi: 10.1016/j.amjsurg.2018.11.020. Epub 2018 Nov 27.