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临床试验/NCT02049372
NCT02049372已完成不适用

Developing a Prospective Registry for Complications in Otorhinolaryngologic Surgery: Tonsil Surgery as a Pilot Cohort

University of Helsinki1 个研究点 分布在 1 个国家目标入组 794 人开始时间: 2011年9月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leif Back

MD PhD

University of Helsinki

研究点 (1)

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