Quality of Life Outcomes Following Minimally Invasive and Open Esophagectomy for Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 1
- 主要终点
- short-term pain
研究概览
简要总结
The goal of this study is to evaluate how surgery for esophageal cancer affects the patient's quality of life over time. The investigators hope this study will provide important information that can be used to improve the quality of life of patients with esophageal cancer. This study will also look at how standard tests and information collected from the patients difficulty swallowing can predict the extent of their esophageal cancer before surgery.
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 or older
- •Diagnosis of esophageal cancer, stages I-IIIC, with no prior esophageal resection. Neoadjuvant therapy given prior to presentation at MSKCC will be accepted.
- •Anticipated to undergo surgical resection (Ivor Lewis, Trans Hiatal, thoracoabdominal, or McKeown procedure) of esophageal cancer either by open or minimally invasive methods
- •Chest and abdomen CT scan
- •Ability to speak read and write English.
排除标准
- •Inability to give informed consent
- •Patients requiring a laryngectomy or colon interposition as part of their surgical resection.
- •Patients with scleroderma.
结局指标
主要结局
short-term pain
时间窗: 4 months
Pain intensity (average of the four pain severity items) measured by BPI at Post-op Days 1 and 3, after epidural removal, at first post-operative clinic visit, at 4 months
short -term quality of life (QOL)
时间窗: 4 months
FACT-E score at the post-op visit and at the 4 months
次要结局
- Complications(90 days)
- long time quality of life (QOL)(2 years)
- long-term pain(2 years)
- differences in surgical outcomes(90 days)