Save Our Surgeons - Differences in Stress of Robot-assisted Laparoscopic Surgery vs. Conventional Laparoscopic Surgery

Study Overview
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Brief Summary
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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

Official Title
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SOS - Save Our Surgeons - Differences in Musculoskeletal and Cognitive Stress of Robot-assisted Laparoscopic Surgery vs. Conventional Laparoscopic Surgery

Conditions
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Excessive Musculoskeletal Stress

Intervention / Treatment
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* Procedure: laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 68 years Able to work in full shift trained surgeons in RALS and CLS written informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RALS<br>Surgeons perform robot-assisted laparoscopic surgery | Procedure: laparoscopic surgery<br>* differences in musculoskeletal and cognitive stress<br>|
| CLS<br>Surgeons perform conventional laparoscopic surgery | Procedure: laparoscopic surgery<br>* differences in musculoskeletal and cognitive stress<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median muscular load of the bilateral trapezius pars descendens muscle surface electromyography. | 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] | 75 Minutes | 
| Static muscular load of the bilateral trapezius pars descendens muscle | 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. | 75 Minutes | 
| sustained muscular activity of the bilateral trapezius pars descendens muscle | 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. | 75 Minutes | 
| Muscular rest time of the bilateral trapezius pars descendens muscle | 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. | 75 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median muscular load of the bilateral extensor digitorum and flexor carpi radials muscles | 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] | 75 Minutes | 
| Static muscular load of the bilateral extensor digitorum and flexor carpi radials muscles | 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 [percentMVE] will be calculated. | 75 Minutes | 
| sustained muscular activity of the bilateral extensor digitorum and flexor carpi radials muscles | 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. | 75 Minutes | 
| Muscular rest time of the bilateral extensor digitorum and flexor carpi radials muscles | 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. | 75 Minutes | 
| Shoulder abduction angle [degree] | Shoulder abduction angle will be assessed by the difference of two gravimetric position sensors placed on the upper back and the lateral side of the upper arm. | 75 Minutes | 
| trunk flexion angle [degree] | Trunk flexion angle will be assessed by the difference of two gravimetric position sensors placed on the upper and lower back. | 75 Minutes | 
| head flexion angle [degreee] | Head flexion angle will be assessed by the difference of two gravimetric position sensors placed on the upper back and the forehead. | 75 Minutes | 
| Frequency of perceived physical discomfort [n] | Subjects will be asked in 20-min intervals throughout the surgery whether they feel any discomfort [yes or no] | 75 Minutes | 
| Intensity of perceived physical discomfort [0-10; 0 = nothing at all, 10 = extremely high | Subjects will be asked in 20 -min intervals throughout the surgery about their level of perceived physical discomfort using a numeric rating scale [0 to 10]. | 75 Minutes | 
| Subjective mental demand [0 - 21; 0 = very low, 21 = very high] | Subjective mental demands will be assessed by the mental demand subscale of the NASA TLX questionnaire | 75 Minutes | 
| heart rate [beats per minute] | Heart rate will be recorded by a one channel electrocardiogram | 75 Minutes | 
| Heart rate variability as the Standard Deviation of NN intervals [ms] | Heart rate will be recorded by a one channel electrocardiogram and the standard Deviation of the NN interval will be calculated | 75 Minutes | 
| Heart rate variability as the Root Mean Squers of Successive Differences [ms] | Heart rate will be recorded by a one channel electrocardiogram and the root mean square of the successive differences will be calculated | 75 Minutes |