- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07542925
Prediction of Postoperative ICU Requirement in Oncologic Surgery
Comparison of ASA, SORT, CACI, and P-POSSUM Scores for Predicting Postoperative Intensive Care Unit Requirement in Patients Undergoing Oncologic Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Busra Uslu YAMAN
- Phone Number: +905068321017
- Email: buslu.1995@gmail.com
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Recruiting
- Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
-
Contact:
- Busra Uslu YAMAN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18 years and older.
- Patients scheduled for elective or emergency oncologic surgery.
- Patients who are able to provide written informed consent.
- Patients whose data will be analyzed for both planned and unplanned intensive care unit (ICU) admissions.
Exclusion Criteria:
- Patients under 18 years of age.
- Patients requiring continuous ICU follow-up due to a pre-existing critical illness prior to the current surgery.
- Patients who do not provide consent to participate in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Oncologic Surgery Patients
Adult patients (≥18 years) undergoing elective or emergency oncologic surgery at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Unplanned Postoperative ICU Admission
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.
|
Up to 24 hours post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-Day All-Cause Mortality
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.
|
Up to 30 days post-surgery
|
|
Duration of ICU Stay (in Days)
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.
|
From date of ICU admission until the date of ICU discharge, assessed up to 30 days post-surgery.
|
|
Number of Participants Requiring Mechanical Ventilation within 24 Hours after Surgery
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.
|
Up to 24 hours post-surgery
|
|
Length of Hospital Stay (in Days)
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.
|
From the date of hospital admission until the date of hospital discharge, assessed up to 90 days.
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Nates JL, Nunnally M, Kleinpell R, Blosser S, Goldner J, Birriel B, Fowler CS, Byrum D, Miles WS, Bailey H, Sprung CL. ICU Admission, Discharge, and Triage Guidelines: A Framework to Enhance Clinical Operations, Development of Institutional Policies, and Further Research. Crit Care Med. 2016 Aug;44(8):1553-602. doi: 10.1097/CCM.0000000000001856.
- Mukherjee S, Kedia A, Goswami J, Chakraborty A. Validity of P-POSSUM in adult cancer surgery (PACS). J Anaesthesiol Clin Pharmacol. 2022 Jan-Mar;38(1):61-65. doi: 10.4103/joacp.JOACP_128_20. Epub 2022 Apr 25.
- Yildirim M, Halacli B, Kaya EK, Ulusoydan E, Ortac Ersoy E, Topeli A. Prognostic Accuracy of Nutritional Assessment Tools in Critically-Ill COVID-19 Patients. J Clin Med. 2025 May 13;14(10):3382. doi: 10.3390/jcm14103382.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-12/193
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Neoplasms
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruitingRectal Neoplasms | Colon Neoplasms | Metagenome | MicrobiotaChina
-
European Association for Endoscopic SurgeryWithdrawn
-
Moscow Clinical Scientific CenterRecruitingCecal Neoplasms | Colonic Neoplasms MalignantRussian Federation
-
H. Lee Moffitt Cancer Center and Research InstituteNot yet recruitingPeritoneal CarcinomatosisUnited States
-
Second Affiliated Hospital, School of Medicine,...RecruitingColonic NeoplasmsChina
-
Nanjing Medical UniversityNot yet recruitingMalignant Meningioma
-
Joshua PalmerRayzeBio, Inc.RecruitingRecurrent MeningiomaUnited States
-
Chang Gung Memorial HospitalNational Science and Technology CouncilRecruiting
-
Intergroupe Francophone de Cancerologie ThoraciqueRegeneron PharmaceuticalsNot yet recruiting
-
Royal North Shore HospitalNorthern Sydney and Central Coast Area Health ServiceRecruiting