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Completed

NCT Number: NCT04352452

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

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

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Key information

Conditions

Excessive Musculoskeletal Stress

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Tuebingen, Department of Women's Health

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic surgery

Procedure

differences in musculoskeletal and cognitive stress

Primary outcomes

  1. Median muscular load of the bilateral trapezius pars descendens muscle surface electromyography.

    Time frame: 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]

  2. Static muscular load of the bilateral trapezius pars descendens muscle

    Time frame: 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.

  3. sustained muscular activity of the bilateral trapezius pars descendens muscle

    Time frame: 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.

  4. Muscular rest time of the bilateral trapezius pars descendens muscle

    Time frame: 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.

Secondary outcomes

  1. Median muscular load of the bilateral extensor digitorum and flexor carpi radials muscles

    Time frame: 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]

  2. Static muscular load of the bilateral extensor digitorum and flexor carpi radials muscles

    Time frame: 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 [percentMVE] will be calculated.

  3. sustained muscular activity of the bilateral extensor digitorum and flexor carpi radials muscles

    Time frame: 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.

  4. Muscular rest time of the bilateral extensor digitorum and flexor carpi radials muscles

    Time frame: 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.

  5. Shoulder abduction angle [degree]

    Time frame: 75 Minutes

    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.

  6. trunk flexion angle [degree]

    Time frame: 75 Minutes

    Trunk flexion angle will be assessed by the difference of two gravimetric position sensors placed on the upper and lower back.

  7. head flexion angle [degreee]

    Time frame: 75 Minutes

    Head flexion angle will be assessed by the difference of two gravimetric position sensors placed on the upper back and the forehead.

  8. Frequency of perceived physical discomfort [n]

    Time frame: 75 Minutes

    Subjects will be asked in 20-min intervals throughout the surgery whether they feel any discomfort [yes or no]

  9. Intensity of perceived physical discomfort [0-10; 0 = nothing at all, 10 = extremely high

    Time frame: 75 Minutes

    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].

  10. Subjective mental demand [0 - 21; 0 = very low, 21 = very high]

    Time frame: 75 Minutes

    Subjective mental demands will be assessed by the mental demand subscale of the NASA TLX questionnaire

  11. heart rate [beats per minute]

    Time frame: 75 Minutes

    Heart rate will be recorded by a one channel electrocardiogram

  12. Heart rate variability as the Standard Deviation of NN intervals [ms]

    Time frame: 75 Minutes

    Heart rate will be recorded by a one channel electrocardiogram and the standard Deviation of the NN interval will be calculated

  13. Heart rate variability as the Root Mean Squers of Successive Differences [ms]

    Time frame: 75 Minutes

    Heart rate will be recorded by a one channel electrocardiogram and the root mean square of the successive differences will be calculated

Other outcomes

  1. Body height [cm]

    Time frame: 5 Minutes

    The Nordic Questionnaire will be used to determine subjects body height Physical activity [hours of sports per week work experience [years] musculoskeletal complaints in the last 12 month, last week, and point prevalence [n]

  2. Body weight [kg]

    Time frame: 5 Minutes

    The Nordic Questionnaire will be used to determine subjects body weight

  3. Physical activity [hours of sports per week]

    Time frame: 5 Minutes

    The Nordic Questionnaire will be used to determine subjects weekly physical activity

  4. work experience [years]

    Time frame: 5 Minutes

    The Nordic Questionnaire will be used to determine subjects work experience

  5. Musculoskeletal complaints in the last 12 month, last week, and point prevalence [n]

    Time frame: 5 Minutes

    The Nordic Questionnaire will be used to determine subjects musculoskeletal complaints in the last 12 month, last week, and point prevalence

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Institute of Occupational and Social Medicine and Health Services Research, Tuebingen

Registry information

Official study title

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

Acronym: SOSII

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2020
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.