SOS - Save Our Surgeons - Differences in Musculoskeletal and Cognitive Stress of Robot-assisted Laparoscopic Surgery vs. Conventional Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Median muscular load of the bilateral trapezius pars descendens muscle surface electromyography.
研究概览
简要总结
Monocentric trial to evaluate differences in musculoskeletal and cognitive stress of robot-assisted laparoscopic surgery (RALS) vs. conventional laparoscopic surgery (CLS). Demographic and personal data are collected and pseudonymized as well as video recordings are performed during surgery. Simultaneously, surface electromyography (EMG) and electrocardiography (ECG), motion tracking data are collected. Additionally, saliva cortisol, perceived discomfort and mental load will be assessed within certain time intervals. The surgeon is not disturbed in his activity and movement by the equipment.
Afterwards, the surgeon will be interviewed in a 15-minute standardized interview about the surgery process and the subjective stress sensitivity. Only routine interventions will be recorded, in case of unforeseen complications, the recording will be stopped immediately
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 68 years
- •Able to work in full shift
- •trained surgeons in RALS and CLS
- •written informed consent
排除标准
- •persons influenced by analgesics or muscle relaxants
- •not being able to work for any reason
- •persons with acute diseases or pain Depending on the degree of severity, persons with diseases of the spine, hand-arm system, muscle disorders, symptomatic neurological-psychiatric disorders, when indicated regular medications, acute pain symptoms, diseases or other current illnesses must be excluded
研究组 & 干预措施
RALS
Surgeons perform robot-assisted laparoscopic surgery
干预措施: laparoscopic surgery (Procedure)
CLS
Surgeons perform conventional laparoscopic surgery
干预措施: laparoscopic surgery (Procedure)
结局指标
主要结局
Median muscular load of the bilateral trapezius pars descendens muscle surface electromyography.
时间窗: 75 Minutes
Muscle activity will be recorded using bipolar surface electromyography and is defined as the root-mean-square (RMS) of electrical muscle activity. Muscle activity will be normalized to an isometric voluntary maximum electrical activation (MVE) and the 50th percentile the normalized RMS will be calculated \[percent MVE\]
Static muscular load of the bilateral trapezius pars descendens muscle
时间窗: 75 Minutes
Muscle activity will be recorded using bipolar surface electromyography and is defined as the root-mean-square (RMS) of electrical muscle activity. Muscle activity will be normalized to an isometric voluntary maximum electrical activation (MVE) and the 10th percentile of the normalized RMS \[percent MVE\] will be calculated.
sustained muscular activity of the bilateral trapezius pars descendens muscle
时间窗: 75 Minutes
Muscle activity will be recorded using bipolar surface electromyography and is defined as the root-mean-square (RMS) of electrical muscle activity. Muscle activity will be normalized to an isometric voluntary maximum electrical activation (MVE) and the number of episodes (≥ 8min) of the normalized RMS above 0.5percent MVE \[n\] will be calculated.
Muscular rest time of the bilateral trapezius pars descendens muscle
时间窗: 75 Minutes
Muscle activity will be recorded using bipolar surface electromyography and is defined as the root-mean-square (RMS) of electrical muscle activity. Muscle activity will be normalized to an isometric voluntary maximum electrical activation (MVE) and the frequency \[n\] and relative duration \[percent\] of the normalized RMS lower than 0.5percent MVE will be calculated.
次要结局
- Frequency of perceived physical discomfort [n](75 Minutes)
- Shoulder abduction angle [degree](75 Minutes)
- trunk flexion angle [degree](75 Minutes)
- heart rate [beats per minute](75 Minutes)
- Heart rate variability as the Root Mean Squers of Successive Differences [ms](75 Minutes)
- Median muscular load of the bilateral extensor digitorum and flexor carpi radials muscles(75 Minutes)
- Static muscular load of the bilateral extensor digitorum and flexor carpi radials muscles(75 Minutes)
- sustained muscular activity of the bilateral extensor digitorum and flexor carpi radials muscles(75 Minutes)
- Intensity of perceived physical discomfort [0-10; 0 = nothing at all, 10 = extremely high(75 Minutes)
- Muscular rest time of the bilateral extensor digitorum and flexor carpi radials muscles(75 Minutes)
- head flexion angle [degreee](75 Minutes)
- Subjective mental demand [0 - 21; 0 = very low, 21 = very high](75 Minutes)
- Heart rate variability as the Standard Deviation of NN intervals [ms](75 Minutes)