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

February 9, 2026 updated by: University Hospital Tuebingen

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Tübingen, Germany, 72076
        • University Hospital Tuebingen, Department of Women's Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
RALS
Surgeons perform robot-assisted laparoscopic surgery
Procedure: laparoscopic surgery
differences in musculoskeletal and cognitive stress
CLS
Surgeons perform conventional laparoscopic surgery
Procedure: laparoscopic surgery
differences in musculoskeletal and cognitive stress

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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]
75 Minutes
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.
75 Minutes
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.
75 Minutes
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.
75 Minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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]
75 Minutes
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.
75 Minutes
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.
75 Minutes
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.
75 Minutes
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.
75 Minutes
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.
75 Minutes
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.
75 Minutes
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]
75 Minutes
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].
75 Minutes
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
75 Minutes
heart rate [beats per minute]
Time Frame: 75 Minutes
Heart rate will be recorded by a one channel electrocardiogram
75 Minutes
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
75 Minutes
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
75 Minutes

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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]
5 Minutes
Body weight [kg]
Time Frame: 5 Minutes
The Nordic Questionnaire will be used to determine subjects body weight
5 Minutes
Physical activity [hours of sports per week]
Time Frame: 5 Minutes
The Nordic Questionnaire will be used to determine subjects weekly physical activity
5 Minutes
work experience [years]
Time Frame: 5 Minutes
The Nordic Questionnaire will be used to determine subjects work experience
5 Minutes
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
5 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Tuebingen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institute of Occupational and Social Medicine and Health Services Research, Tuebingen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Sara Brucker, Prof. Dr., Department of Women's Health, University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MT_SOS II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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