Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:21 PM
Study NCT ID:
NCT07325656
Status:
COMPLETED
Last Update Posted:
2026-01-20
First Post:
2025-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Scoring Systems in Gastrointestinal Cancer Surgery
Sponsor:
Lütfi Kırdar City Hospital
Organization:
Study Overview
Official Title:
Comparison of Scoring Systems for Predicting Morbidity and Mortality in Patients Undergoing Surgery for Gastrointestinal Malignancies
Status:
COMPLETED
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Accurate prediction of postoperative morbidity and mortality is essential for optimizing perioperative management in patients undergoing gastrointestinal cancer surgery. This study evaluates the predictive performance of commonly used perioperative risk scoring systems in patients undergoing gastrointestinal surgery for malignancy under general anesthesia.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: