- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07325656
Comparison of Scoring Systems in Gastrointestinal Cancer Surgery
Comparison of Scoring Systems for Predicting Morbidity and Mortality in Patients Undergoing Surgery for Gastrointestinal Malignancies
Study Overview
Status
Conditions
Detailed Description
This prospective observational study is designed to assess the predictive accuracy of multiple perioperative risk assessment tools in adult patients undergoing gastrointestinal (GI) surgery for malignancy under general anesthesia. Preoperative risk stratification is a key component of perioperative care, as it supports identification of patients at increased risk for postoperative complications and mortality and facilitates appropriate perioperative planning and resource utilization.
Perioperative risk scores are calculated using routinely collected clinical data obtained during the preoperative evaluation and intraoperative period, in accordance with established definitions for each scoring system. The scoring systems evaluated include the American Society of Anesthesiologists Physical Status classification (ASA-PS), Surgical Apgar Score (SAS), Portsmouth Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (P-POSSUM), American College of Surgeons National Surgical Quality Improvement Program Surgical Risk Calculator (ACS-NSQIP-SRC), and the ARISCAT risk score for postoperative pulmonary complications.
Postoperative outcomes are assessed during the index hospitalization and early postoperative follow-up period, focusing on the occurrence of pulmonary and non-pulmonary complications, short-term mortality, requirement for intensive care unit admission, and length of hospital and intensive care unit stay.
The primary objective of the study is to determine which perioperative risk assessment tools demonstrate the highest predictive accuracy for postoperative complications and mortality following gastrointestinal malignancy surgery. Secondary objectives include comparison of score performance for pulmonary versus non-pulmonary complications and evaluation of associations between risk scores and postoperative length of stay.
The results of this study are expected to provide clinically relevant evidence regarding the utility of commonly used perioperative risk scoring systems in gastrointestinal cancer surgery and to support improved perioperative risk stratification.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kartal
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Istanbul, Kartal, Turkey (Türkiye), 34899
- Kartal Dr. Lütfi Kirdar City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: Age ≥ 18 years, Scheduled to undergo elective gastrointestinal surgery for malignancy via laparotomy, Planned general anesthesia, Provision of written informed consent
Exclusion Criteria: Emergency surgery, Surgery performed using laparoscopic or robotic approaches, Previous gastrointestinal surgery for malignancy within the past 6 months, Inability to provide informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Gastrointestinal Cancer Surgery Cohort
Prospective observational group including adult patients undergoing elective surgery for gastrointestinal malignancy.
Risk prediction scores will be recorded pre- and peri-operatively.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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30- and 60-day All-Cause Postoperative Mortality
Time Frame: 60 days after surgery
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All-cause mortality within 30 and 60 days after gastrointestinal malignancy surgery performed under general anesthesia.
Mortality data will be obtained from hospital records and verified through national health databases.
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60 days after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Pulmonary Complications
Time Frame: Within 30 days after surgery
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Occurrence of any pulmonary complication including pneumonia, respiratory failure requiring reintubation or mechanical ventilation >24 hours, bronchospasm, pulmonary edema, or atelectasis as defined by ARISCAT/EPCO criteria.
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Within 30 days after surgery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Non-Pulmonary Complications
Time Frame: Within 30 days after surgery
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Occurrence of any non-pulmonary postoperative complication such as wound infection, sepsis, acute kidney injury, postoperative bleeding, cardiac event (arrhythmia, myocardial infarction, heart failure), or ileus.
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Within 30 days after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: MEHMET E GECICI, MD, Kartal Dr. Lütfi Kirdar City Hospital
Publications and helpful links
General Publications
- Nag DS, Dembla A, Mahanty PR, Kant S, Chatterjee A, Samaddar DP, Chugh P. Comparative analysis of APACHE-II and P-POSSUM scoring systems in predicting postoperative mortality in patients undergoing emergency laparotomy. World J Clin Cases. 2019 Aug 26;7(16):2227-2237. doi: 10.12998/wjcc.v7.i16.2227.
- Vashistha N, Singhal S, Budhiraja S, Singhal D. Evaluation of ACS-NSQIP and CR-POSSUM risk calculators for the prediction of mortality after colorectal surgery: A retrospective cohort study. J Minim Access Surg. 2024 Apr 1;20(2):142-147. doi: 10.4103/jmas.jmas_187_22. Epub 2022 Sep 12.
- Crea N, Di Fabio F, Pata G, Nascimbeni R. APACHE II, POSSUM, and ASA scores and the risk of perioperative complications in patients with colorectal disease. Ann Ital Chir. 2009 May-Jun;80(3):177-81.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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