Clinical trial · Observational
Frailty Score and Postoperative Morbidity in Colorectal Cancer Surgery
Can the Frailty Score Independently Predict Surgical Risk and Postoperative Morbidity in Patients With Colorectal Cancer?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Frailty | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational Data Collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Frail
- description
- 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.
- interventionNames
- Procedure: Observational Data Collection
- label
- Non-Frail
- description
- 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.
- interventionNames
- Procedure: Observational Data Collection
Primary outcomes (1)
- measure
- Postoperative Complication Rate Postoperative Complication Rate (Clavien-Dindo ≥ Grade II)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDSchmucker 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. PMID 31105984
- BACKGROUNDGiger 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. PMID 39034167
- BACKGROUNDAucoin 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. PMID 32243326
- BACKGROUNDElsamadicy 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. PMID 34010683
- BACKGROUNDCook 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. PMID 36571779
- BACKGROUNDPanayi 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. PMID 30509455