Postoperative Hypoxemia Increases the Risk of Anastomotic Leak After Radical Esophagectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 6
- 主要终点
- Esophageal Anastomotic Leakage Rate
研究概览
简要总结
This study aims to determine whether postoperative hypoxia (arterial partial pressure of oxygen (PaO₂)<80 mmHg) is an independent risk factor for anastomotic leakage after esophagectomy. The investigators conducted a retrospective analysis of cases from their center over the past five years, stratifying patients into Low Pa0₂ Group and Normal Pa0₂ Group based on postoperative oxygen levels and comparing the incidence of anastomotic leakage between the groups. The goal is to establish whether hypoxia is a causative risk factor and whether correcting it can reduce the risk of anastomotic leakage.
详细描述
This retrospective study included all patients who underwent radical esophagectomy at our center over the past five years. After screening based on inclusion and exclusion criteria, PaO₂ levels within the first postoperative week were recorded (the lowest value was used if multiple measurements were taken on the same day), along with whether the condition improved after corrective interventions, patients were accordingly divided into Low Pa0₂ Group (at least one recorded instance of PaO₂ <80 mmHg) and Normal Pa0₂ Group. Anastomotic leakage was diagnosed based on barium swallow, endoscopy, chest-abdominal CT, or typical clinical signs. By comparing the incidence of anastomotic leakage between the two groups, the relationship between postoperative PaO₂ and anastomotic leakage was analyzed, with further investigation into whether postoperative hypoxemia constitutes an independent and modifiable risk factor.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with esophageal carcinoma or benign esophageal tumors
- •Patients requiring surgical resection of the lesion with subsequent esophageal reconstruction
- •Patients must have had at least one postoperative arterial blood gas analysis
- •Patients must have routinely undergone at least one of the following for postoperative evaluation of the anastomosis: endoscopy, CT scan, or esophagram
排除标准
- •Patients who did not require esophageal reconstruction
- •Patients undergoing esophageal replacement with colon
- •Patients with incomplete data
研究组 & 干预措施
Low Pa02 Group
Patients were defined as belonging to the Low PaO₂ group if they exhibited at least one recorded instance of PaO₂ <80 mmHg within the first postoperative week.
Normal PaO2 Group
Patients maintained a PaO₂ ≥80 mmHg throughout the first postoperative week.
结局指标
主要结局
Esophageal Anastomotic Leakage Rate
时间窗: From the date of surgery to 30 days postoperatively
Anastomotic leak was confirmed by either barium swallow study, CT scan, or endoscopy, or was clinically considered in cases with obvious salivary secretion from the cervical anastomosis. The esophageal anastomotic leakage rate was calculated as (the number of patients with a confirmed anastomotic leakage / the total number of patients who underwent esophagectomy) × 100%.
次要结局
未报告次要终点
研究者
Yang Hong
Professor
Sun Yat-sen University