NCT02836535已完成不适用
The Patient-Perspective of Complications After Colon and Rectum Surgery: A Qualitative Analysis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of complications
研究概览
简要总结
The purpose of this study is to understand the patient experience with an adverse event after surgery. An adverse event is an undesirable experience or complication associated with your surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Patients who had elective surgery for a primary colorectal cancer within the last 90 days.
- •Patients who either:
- •Develop an eligible complication (Appendix 1) within 30 days of surgery (n = 25 - 30)
- •Do not develop any complication after surgery (n = 25 - 30)
排除标准
- •Multivisceral resections
- •Metastatic or locally-recurrent disease
- •Physical impairment that may prevent participation in an interview or survey setting
- •Active psychiatric illness, cognitive or sensory impairment
- •Inability to speak or understand English
- •Refusal to participate in an audio-recorded interview
- •Inability to participate in an audio-recorded interview for reasons not otherwise specified
- •Any second surgical procedure unrelated to the complication within the 90-day period
结局指标
主要结局
Number of complications
时间窗: within 90 days
Information gathered from these interviews will form the basis for the conceptual model of surgical complications. Qualitative data will be obtained from patients who have directly experienced a surgical complication. These complications are defined and categorized by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
次要结局
未报告次要终点
研究者
研究点 (1)
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