Institutional Outcome Data From Per-oral Plication of the Esophagus (POPE)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Patient Reported Outcomes using the CONDUIT patient questionnaire.
研究概览
简要总结
Researchers are reviewing and analyzing surgical and clinical outcomes of subjects who underwent POPE for end-stage achalasia, a sigmoid esophagus, or a redundant conduit that has been used to replace the esophagus. This data will help researchers determine the safety and efficacy of a novel minimally invasive treatment compared to invasive surgery.
详细描述
Researchers will be collecting electronic medical data for subjects who have already undergone Per-oral Plication of the Esophagus (POPE) procedure. Subject characteristics, radiographic documentation, videos, procedural details, and subject reported outcomes would be collected. This data will be used for review and analysis to answer questions aimed in this study. Data collected from this study will be entered into a database that will be maintained for future research.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Adults > 18 years of age
- •Patients who have already undergone Per-oral Plication of the Esophagus (POPE) procedure
排除标准
- •Patients <18 years of age
结局指标
主要结局
Patient Reported Outcomes using the CONDUIT patient questionnaire.
时间窗: 01/01/2017-9/17/2018
Evaluate efficacy by reviewing patient reported outcomes of the novel minimally invasive treatment compared to invasive surgery.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 01/01/2017-9/17/2018
Evaluate safety by assessment of adverse events of the novel minimally invasive treatment compared to invasive surgery.
次要结局
未报告次要终点