Audio Recording During Laparoscopic Surgery - The Impact on Conversation Between Surgeons
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Non-relevant conversation
研究概览
简要总结
In september 2017 audio recording during laparoscopic general surgery was implemented as routine a Lindesbergs hospital. The study was designed to observe operations before and after the introduction of audio recording. The main outcome of the study was time spent on non-relevant conversation.
详细描述
In september 2017 audio recording during laparoscopic general surgery was implemented as routine a Lindesbergs hospital. One single observer not working at the department observed consecutive operations before and after the introduction of audio recordings. All elective laparoscopic procedures were included. There was no available data to support a Power-calculation why we intended to include 20 patients in each arm of the study. Exclusion criteria were refusal of operating team or patient to participate in the study, or planned open surgery. Potential disturbances were recorded by the observer. The main outcome was time with non-relevant conversation (for the operation or as part of education).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Open label
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
- •Elective laparoscopic general surgery -
排除标准
- •R, planned open surgery, refusal to participate (patient or operating team)
结局指标
主要结局
Non-relevant conversation
时间窗: Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)
Time spent on non-relevant conversation
次要结局
- Operation time(Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place))
- Corrections of assistant surgeon(Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place))
- Postoperative complication(30 days after surgery)
- Intraoperative unplanned event(Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place))
研究者
Erik Stenberg, MD, PhD
Principal Investigator
Region Örebro County