Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, Turkey (Türkiye)
Location status: Recruiting
Location contact
Busra Uslu YAMAN
CONTACT
NCT Number: NCT07542925
This prospective observational cohort study aims to compare the performance of commonly used perioperative risk scoring systems in predicting postoperative intensive care unit (ICU) requirement among adult patients undergoing oncologic surgery. Accurate prediction of postoperative ICU admission is essential for optimizing patient safety and efficient allocation of limited critical care resources, particularly in high-risk oncologic surgical populations.
A total of 500 adult patients scheduled for elective or emergency oncologic surgery will be prospectively enrolled at a single tertiary oncology center. Preoperative clinical and demographic data, intraoperative variables, and perioperative characteristics will be recorded using a standardized data collection form. Risk assessment will include the American Society of Anesthesiologists (ASA) Physical Status classification, Surgical Outcome Risk Tool (SORT), Age-adjusted Charlson Comorbidity Index (CACI), Portsmouth Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM), Eastern Cooperative Oncology Group (ECOG) performance status, Nutritional Risk Screening 2002 (NRS-2002), and preoperative serum albumin levels.
The primary outcome is the need for postoperative ICU admission within the first 24 hours after surgery. Secondary outcomes include unplanned ICU admission, duration of ICU stay, need for mechanical ventilation, hospital length of stay, and 30-day mortality. The predictive performance of each scoring system will be evaluated using receiver operating characteristic (ROC) analysis and multivariable logistic regression models.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Ankara, Turkey (Türkiye)
Location status: Recruiting
Busra Uslu YAMAN
CONTACT
Postoperative intensive care unit (ICU) admission represents a critical component of perioperative management, particularly in patients undergoing oncologic surgery who frequently present with advanced age, multiple comorbidities, impaired functional capacity, and increased perioperative risk. Accurate preoperative identification of patients requiring postoperative critical care is essential to improve patient outcomes, optimize perioperative planning, and ensure appropriate allocation of limited ICU resources.
Several perioperative risk assessment tools are routinely used in clinical practice, including the American Society of Anesthesiologists (ASA) Physical Status classification, the Surgical Outcome Risk Tool (SORT), and the Age-adjusted Charlson Comorbidity Index (CACI). However, comparative prospective evidence regarding their ability to predict postoperative ICU requirement remains limited. The Portsmouth Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM), which incorporates both physiological and operative variables, may provide additional prognostic value beyond traditional preoperative scoring systems. Furthermore, functional status and nutritional condition are increasingly recognized as important determinants of surgical outcomes in oncology patients. Therefore, inclusion of Eastern Cooperative Oncology Group (ECOG) performance status, Nutritional Risk Screening 2002 (NRS-2002), and preoperative serum albumin levels may enhance predictive accuracy.
This study is designed as a single-center prospective observational cohort study enrolling adult patients undergoing elective or emergency oncologic surgery. Eligible patients aged 18 years or older will be consecutively included and followed throughout the perioperative period. Preoperative demographic and clinical characteristics, intraoperative variables, and perioperative management data will be recorded using a standardized data collection system.
The primary objective of the study is to evaluate and compare the predictive performance of ASA, SORT, CACI, P-POSSUM, ECOG performance status, and NRS-2002 scores for postoperative ICU requirement within the first 24 hours after surgery. Secondary objectives include assessment of unplanned ICU admission, mechanical ventilation requirement, ICU length of stay, hospital length of stay, and 30-day mortality.
Predictive performance will be evaluated using receiver operating characteristic (ROC) curve analysis with calculation of area under the curve (AUC) values. Differences between scoring systems will be assessed using appropriate statistical comparison methods, and multivariable logistic regression analysis will be performed to determine independent predictors of postoperative ICU requirement while adjusting for potential confounding variables.
The findings of this study are expected to support evidence-based perioperative risk stratification and contribute to improved clinical decision-making regarding postoperative critical care planning in oncologic surgical patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The study evaluates the predictive performance of various risk scoring systems for postoperative intensive care unit (ICU) requirement in adult patients undergoing oncologic surgery. Preoperative and intraoperative data will be collected to calculate ASA, SORT, CACI, P-POSSUM, ECOG, and NRS-2002 scores. The primary outcome is the need for ICU admission within the first 24 hours postoperatively.
Time frame: Up to 24 hours post-surgery
The number of participants with an unplanned admission to the ICU within the first 24 hours following oncological surgery.
Time frame: Up to 30 days post-surgery
All-cause mortality is defined as any death, regardless of cause, occurring within 30 days following surgery. Mortality data will be collected from hospital records and verified by follow-up (including telephone contact if required). Both in-hospital deaths and deaths occurring after discharge within the 30-day postoperative period will be included in the analysis.
Time frame: From date of ICU admission until the date of ICU discharge, assessed up to 30 days post-surgery.
Total number of days spent in the intensive care unit from the date of ICU admission until the date of ICU discharge during the index hospitalization.
Time frame: Up to 24 hours post-surgery
Mechanical ventilation requirement is defined as the need for invasive ventilatory support within the first 24 hours after surgery. Data will be obtained from anesthesia and postoperative care records.
Time frame: From the date of hospital admission until the date of hospital discharge, assessed up to 90 days.
Total number of days from hospital admission to official hospital discharge.
Contact information is provided by the study sponsor or research team.
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Other
Comparison of ASA, SORT, CACI, and P-POSSUM Scores for Predicting Postoperative Intensive Care Unit Requirement in Patients Undergoing Oncologic Surgery
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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.
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