Prediction of Postoperative ICU Requirement in Oncologic Surgery

NCT07542925 | Recruiting

• 1 other identifier: 2025-12/193
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoplasms; Postoperative Complications; Perioperative/Postoperative Complications; Intensive Care Units

Outcome Measures

Primary Outcomes (1)

• Incidence of Unplanned Postoperative ICU Admission

  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 Outcomes (4)

• 30-Day All-Cause Mortality

  Up to 30 days post-surgery

• Duration of ICU Stay (in Days)

  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

  Up to 24 hours post-surgery

• Length of Hospital Stay (in Days)

  From the date of hospital admission until the date of hospital discharge, assessed up to 90 days.

Study Arms (1)

Oncologic Surgery Patients

Adult patients (≥18 years) undergoing elective or emergency oncologic surgery at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital.

Other: Risk Assessment Scoring Systems (ASA, SORT, CACI, P-POSSUM, ECOG, NRS-2002)

Interventions

Risk Assessment Scoring Systems (ASA, SORT, CACI, P-POSSUM, ECOG, NRS-2002) OTHER

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.

Oncologic Surgery Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (aged 18 and older) who are scheduled to undergo elective or emergency oncologic surgery at a single tertiary oncology training and research hospital. The population includes patients with various types of cancer requiring surgical intervention, where postoperative intensive care unit (ICU) requirement needs to be predicted using clinical risk scoring systems.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital: lead

Study Sites (1)

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 27428118 BACKGROUND

• 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.

  PMID: 35706623 BACKGROUND

• 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.

  PMID: 40429378 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Busra Uslu YAMAN

CONTACT

+905068321017; buslu.1995@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: April 21, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)