Excessive Musculoskeletal StressSOSIINCT04352452
Save Our Surgeons - Differences in Stress of Robot-assisted Laparoscopic Surgery vs. Conventional Laparoscopic Surgery
An observational study of Excessive Musculoskeletal Stress, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Excessive Musculoskeletal Stress
- What is being tested?
- laparoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2019to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female gynecological surgeons who are experienced and must have performed a theoretical and virtual reality based training program in robotic assisted surgery.
Who may be able to join
- Age between 18 and 68 years
- Able to work in full shift
- trained surgeons in RALS and CLS
- written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Tuebingen, Department of Women's Health
Tübingen, 72076
About this study
Official title: SOS - Save Our Surgeons - Differences in Musculoskeletal and Cognitive 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
- Conditions
- Excessive Musculoskeletal Stress
- Being tested
- laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic surgeryProcedure or surgery
differences in musculoskeletal and cognitive stress
| Study group | Role | What they receive |
|---|---|---|
| RALS | Surgeons perform robot-assisted laparoscopic surgery Receives: Procedure: laparoscopic surgery | |
| CLS | Surgeons perform conventional laparoscopic surgery Receives: Procedure: laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 75 Minutes
Secondary outcomes (13)
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]
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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]
Measured: 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].
Measured: 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
Measured: 75 Minutes
heart rate [beats per minute]
Heart rate will be recorded by a one channel electrocardiogram
Measured: 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
Measured: 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
Measured: 75 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 Jun 2019
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Musculoskeletal StressStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Occupational and Social Medicine and Health Services Research, Tuebingen
- Responsible party
- Sponsor
- Investigators
- Sara Brucker, Prof. Dr., Study chair, Department of Women's Health, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352452
- Sponsor's protocol ID
- MT_SOS II
- Acronym
- SOSII
- Status last verified
- Nov 2022
- First submitted
- 28 Feb 2019
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOS - Save Our Surgeons - Differences in Musculoskeletal and Cognitive Stress of Robot-assisted Laparoscopic Surgery vs. Conventional Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT04352452
- Acronym / sponsor ID
- SOSII / MT_SOS II
- Conditions
- Excessive Musculoskeletal Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Institute of Occupational and Social Medicine and Health Services Research, Tuebingen
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RALS | – | Procedure: laparoscopic surgerySurgeons perform robot-assisted laparoscopic surgery |
| CLS | – | Procedure: laparoscopic surgerySurgeons perform conventional laparoscopic surgery |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female gynecological surgeons who are experienced and must have performed a theoretical and virtual reality based training program in robotic assisted surgery.
Key inclusion criteria (4 listed)
- Age between 18 and 68 years
- Able to work in full shift
- trained surgeons in RALS and CLS
- written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic surgerydifferences in musculoskeletal and cognitive stress | Procedure or surgery | CLS, RALS |
Primary outcome
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]
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.
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.
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.
13 secondary outcomes
Median muscular load of the bilateral extensor digitorum and flexor carpi radials muscles
Time frame: 75 Minutes
Static muscular load of the bilateral extensor digitorum and flexor carpi radials muscles
Time frame: 75 Minutes
sustained muscular activity of the bilateral extensor digitorum and flexor carpi radials muscles
Time frame: 75 Minutes
Muscular rest time of the bilateral extensor digitorum and flexor carpi radials muscles
Time frame: 75 Minutes
Shoulder abduction angle [degree]
Time frame: 75 Minutes
trunk flexion angle [degree]
Time frame: 75 Minutes
head flexion angle [degreee]
Time frame: 75 Minutes
Frequency of perceived physical discomfort [n]
Time frame: 75 Minutes
Intensity of perceived physical discomfort [0-10; 0 = nothing at all, 10 = extremely high
Time frame: 75 Minutes
Subjective mental demand [0 - 21; 0 = very low, 21 = very high]
Time frame: 75 Minutes
heart rate [beats per minute]
Time frame: 75 Minutes
Heart rate variability as the Standard Deviation of NN intervals [ms]
Time frame: 75 Minutes
Heart rate variability as the Root Mean Squers of Successive Differences [ms]
Time frame: 75 Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Brucker, Prof. Dr. study chair
Department of Women's Health, University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Excessive Musculoskeletal Stress, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median muscular load of the bilateral trapezius pars descendens muscle surface electromyography. (time frame: 75 Minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.