Surgical Procedures for Advanced Tumor Disease. A Prospective Study Evaluating Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Quality of life 4 weeks after palliative surgery
研究概览
简要总结
Patients in a known palliative setting and with localized symptoms due to tumor growth will be evaluated for their quality of life before and after a surgical intervention (primary endpoint). Medical outcome in terms of length of stay in hospital, length of stay on a intensive care unit, complications, reinterventions will be recorded (secondary endpoints). The investigators will also observe patients with conservative treatment.
详细描述
What is the impact on quality of life by operations in symptomatic advanced tumor disease ? After informed consent patients in known palliative situations and with localized symptoms due to tumor growth will be enrolled in our study. The investigators will assess Quality of life with the EORTC QLQ C30-questionnaire and collect data about the disease an the actual state of the patients.
By the time of discharge out of hospital the investigators will hand out the questionnaire again and the investigators will collect data regarding the therapies, operations, complications, reinterventions, time spent on a intensive care unit, time spent in hospital.
The questionnaire will be completed after 4 and 12 weeks as well.
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
- •informed consent
- •tumor patients within a known palliative situation, patients do know about the absence of a curative treatment
- •patients are symptomatic because of localized tumor growth
- •patients having an operation for symptom relief or treated without surgery
排除标准
- •patients with an only intraoperatively seen palliative tumor disease
- •debulking operations, prophylactic operations for prevention of symptoms, operations for venous access (an exception will be made for enteric bypass operations in patients with a yet preserved passage)
- •dementia, age ≤ 18, barrier of speech
结局指标
主要结局
Quality of life 4 weeks after palliative surgery
时间窗: 4 weeks after palliative surgery
Quality of life will be measured by the questionnaire EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer-Quality of Life).
次要结局
- duration of stay in hospital(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- duration of stay in an intensive care unit(participants will be followed for the duration of stay in an intensive care unit, an expected average of 0 to 2 days)
- complications(the participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- reoperations(the participants will be followed for the duration of hospital stay, an expected average of 2 weeks)