Comparison of Scoring Systems for Predicting Morbidity and Mortality in Patients Undergoing Surgery for Gastrointestinal Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 30- and 60-day All-Cause Postoperative Mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, Scheduled to undergo elective gastrointestinal surgery for malignancy via laparotomy, Planned general anesthesia, Provision of written informed consent
排除标准
- •Emergency surgery, Surgery performed using laparoscopic or robotic approaches, Previous gastrointestinal surgery for malignancy within the past 6 months, Inability to provide informed consent
研究组 & 干预措施
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.
结局指标
主要结局
30- and 60-day All-Cause Postoperative Mortality
时间窗: 60 days after surgery
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.
次要结局
- Postoperative Pulmonary Complications(Within 30 days after surgery)
研究者
Mehmet Emre Gecici
Specialist Physician
Lütfi Kırdar City Hospital