Sex Differences in Gastrointestinal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 870,754
- 主要终点
- Mortality rate
研究概览
简要总结
This study aims to investigate whether there are differences in surgical outcomes between male and female patients with gastrointestinal cancers (esophagus, colon, rectum, stomach, or pancreas). Previous research suggests that women may have worse outcomes after high-risk surgeries, such as heart or vascular procedures, but it is unclear if this applies to gastrointestinal cancer surgery. The study will analyze population based data from Germany to compare how often male and female patients died or died after the occurence of a surgical complication (failure to rescue) after surgery. The goal is to determine if biological sex influences surgical risks and recovery, which could help improve personalized care for cancer patients.
详细描述
DATA SOURCE
As database the German diagnosis-related group statistic (DRG statistic) will be queried. The dataset is provided by the German Federal Statistical Office. It includes standardized demographic information (age, sex), diagnostic codes (ICD-10-GM), procedural codes (OPS), and outcomes (mortality, length of stay, complications). Patients will be included if they underwent resection for one of the five specified cancers; exclusions applied for age <18 years, missing sex/age data, or non-matching diagnosis-procedure pairs.
OUTCOMES
Primary Endpoints:
Mortality: Death during the hospital stay. Failure-to-Rescue (FTR): Death among patients who developed postoperative complications (defined via appropriate ICD-10-GM/OPS codes)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •at least 18 years old at the time of the operation
- •Rectum resection for carcinoma (ICD-10: C19, C20, C218, D01.1, D01.2) and appropriate resection procedure (5-484, 5-485)
- •Colon resection for carcinoma (ICD-10: C18, D01.0) and appropriate resection procedure (5-455, 5-456, 5-458)
- •Complex esophageal surgery for carcinoma (ICD-10: C15, C16.0) and appropriate resection procedure (5-423, 5-424, 5-425, 5-426, 5-427.0, 5-427.1, 5-438.0, 5-438.1, 5-438.x)
- •Pancreatic resection for carcinoma (ICD-10: C25, C24.1) and appropriate resection procedure (5-524, 5-525.0, 5-525.1, 5-525.2, 5-525.x, 5-525.y, 5-528)
- •Gastric resection for carcinoma (ICD-10: C16) and appropriate resection procedure (5-436, 5-437, 5-438)
排除标准
- •missing data for age and/or sex
- •implausible combination of diagnosis and resection procedure (eg. a patient with a gastrectomy but without appropriate ICD-10 diagnosis)
结局指标
主要结局
Mortality rate
时间窗: Up to 90 days postoperatively
Proportion of patients that died after surgical intervention
Failure to rescue
时间窗: Up to 90 days postoperatively
Proportion of patients that died after the occurence of a postoperative complication
次要结局
- Intensive Care Unit admission(Up to 90 days postoperatively)
- Failure to rescue(Up to 90 days postoperatively)
- Complication rate(Up to 90 days postoperatively)
- Reoperation rate(Up to 90 days postoperatively)
- Prolonged Lenght of Stay(Up to 90 days postoperatively)
研究者
Richard Hunger
Senior research assistant
Medizinische Hochschule Brandenburg Theodor Fontane