Developing a Prospective Registry for Complications in Otorhinolaryngologic Surgery: Tonsil Surgery as a Pilot Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 794
- 试验地点
- 1
- 主要终点
- Complication
研究概览
简要总结
Our aim was to establish a feasible method to prospectively register all tonsil surgery-related complications and to find their possible predictive factors. Our long-term objective is to create a surgical complication registration database, which would provide valuable information for quality assurance and give us a benchmarking tool to improve the results of this surgery in our department.
详细描述
In a six-month period all patients undergoing tonsillectomy or tonsillotomy with or without adenoidectomy were assessed for enrolment. Demographic and clinical data were recorded prospectively in a database which included 57 variables, such as age, gender, co-morbidities, body mass index, American Society of Anesthesiologists Physical Status Classification, indication for surgery, educational level of surgeon (consultant vs. resident), surgical technique, duration of operation and length of hospital stay.
After the operation, all patients were given instructions to contact our emergency department (ED) if experiencing any adverse event. Incidents of postoperative complications were recorded during the post-surgical visits to the ED. Only complications warranting a visit to the outpatient department or hospital admission were registered.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no age limits
- •elective tonsillar surgery
排除标准
- •procedures carried out due to malignancy
- •as a part of multilevel surgery for obstructive sleep apnea
- •re-tonsillectomies
- •acute operations
结局指标
主要结局
Complication
时间窗: September 2011 - February 2012 (6 months)
After the operation, all patients were given instructions to contact our emergency department (ED) if experiencing any adverse event. Incidents of postoperative complications were recorded during the post-surgical visits to the ED. Only complications warranting a visit to the outpatient department or hospital admission were registered.
次要结局
- Hospital stay(September 2011 - February 2012 (6 months))
研究者
Leif Back
MD PhD
University of Helsinki
