Comparison of Scoring Systems for Predicting Morbidity and Mortality in Patients Undergoing Surgery for Gastrointestinal Malignancies
Conditions: Gastro Intestinal Cancer, Scoring Systems
Sponsor: Lütfi Kırdar City Hospital

STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN
Official Study Title:
Comparison of Scoring Systems in Predicting Morbidity and Mortality in Patients Undergoing
Gastrointestinal Malignancy Surgery
ClinicalTrials.gov Identifier:
NCTXXXXXXXX (Not yet assigned)
Document Date:
27 January 2021

1. Study Rationale and Objectives
This prospective observational study aims to evaluate and compare the predictive accuracy of
perioperative risk scoring systems in patients undergoing gastrointestinal malignancy surgery. The
primary objective is to assess the sensitivity of ASA, SAS, Portsmouth-POSSUM, ACS-NSQIP,
and ARISCAT scores in predicting postoperative mortality. Secondary objectives include
evaluating the ability of these scores to predict postoperative pulmonary and extrapulmonary
complications, ICU admission, and length of hospital and ICU stay.
2. Study Design
This is a single-center, prospective observational study conducted at a tertiary referral hospital. No
additional interventions beyond routine clinical care will be performed.
3. Study Population
Adult patients aged 18 years or older undergoing elective gastrointestinal malignancy surgery under
general anesthesia who provide written informed consent will be included.
4. Outcome Measures
Primary outcome: postoperative mortality (30-day and 60-day). Secondary outcomes: postoperative
pulmonary and extrapulmonary complications, ICU admission, length of hospital stay, and ICU
stay.
5. Data Collection
Preoperative, intraoperative, and postoperative data will be collected prospectively. Mortality data
will be assessed at 30 and 60 days using hospital records and telephone follow-up.
6. Statistical Analysis Plan
Statistical analyses will be performed using SPSS version 22.0. Continuous variables will be
presented as mean ± standard deviation or median (interquartile range). Categorical variables will
be presented as frequencies and percentages. Receiver operating characteristic (ROC) curve
analysis will be used to assess the predictive performance of each scoring system. Sensitivity,
specificity, and area under the curve (AUC) values will be calculated. A p-value < 0.05 will be
considered statistically significant.
7. Ethical Considerations
The study was approved by the local ethics committee prior to patient enrollment. Written informed
consent will be obtained from all participants. All data will be anonymized and handled
confidentially.

Principal Investigator
Name and Signature: ____________________________
Date: ____________________