Patient Reported Outcome After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- What influences pain related impairment after bariatric surgery
研究概览
简要总结
Prospective association study to analyse patients' outcome after bariatric surgery.
Outcome comprises postoperative pain, analgesia, postoperative side-effects, long-lasting pain, patients' impairment in daily living.
详细描述
Background
Bariatric surgery is a common procedure. Data on patient related outcome beyond loss of body weight are scarce. The question arises which patient is at specific risk for an unfavorable outcome after bariatric surgery.
Objective
The aim of this study is to investigate variables possibly associated with impaired outcome and increased patients' interference after bariatric surgery. Which patients are at risk for clinically meaningful impaired daily living?
Methods
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
- 是
入选标准
- •18 years and older
- •Written informed consent
- •Elective bariatric surgery
- •Patients' ability to understand the purpose of the study
排除标准
- •No informed consent
- •Cognitive impairment
研究组 & 干预措施
All patients
Patients undergoing elective surgery with anesthesia
结局指标
主要结局
What influences pain related impairment after bariatric surgery
时间窗: First day after surgery
Measured by the validated International Pain Outcomes Questionnaire: Patient reported outcome using the numeric rating scale 0-10 (0=no impairment, 10=worst experience possible). Patients with severe pan (pain scores of NRS 6 and higher) are compared to those with no and mild pain.
次要结局
- Change in pain related outcome after bariatric surgery(Up to 12 months after surgery)
- Change in interference with daily activities after bariatric surgery(Up to to 5 years after surgery)
- Change in quality of life after bariatric surgery(Up to 5 years after surgery)