Musculoskeletal Diseases or ConditionsERCONNCT06109753
Ergonomic Benefits From Robotically Assisted Laparoscopy for Hysterectomies and Other Indications
An observational study of Musculoskeletal Diseases or Conditions, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This is a prospective, single-center, observational clinical trial at the Department of Women's Health of the University Hospital Tübingen. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases or Conditions
- What is being tested?
- Robotically Assisted Laparoscopic Surgery and Conventional Laparoscopic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 4 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2023to 31 Jan 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 4 (males and females) gynecological surgeons
Who may be able to join
- Age between 18 and 68 years
- surgeons that are 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
- persons not able to perform their common work for any reason
- persons with acute diseases
- muscle injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ergonomic Benefits From Robotically Assisted Laparoscopy for Hysterectomies and Other Selected Indications in Comparison to Conventional Laparoscopy - an Explorative Study
This is a prospective, single-center, observational clinical trial at the Department of Women's Health of the University Hospital Tübingen.
Read the detailed description
Monocentric trial to evaluate differences in musculoskeletal and cognitive demands of robot-assisted laparoscopic surgery (RALS) vs. conventional laparoscopic surgery (CLS). Demographic and personal data are collected and pseudonymized. During surgery surface electromyography (EMG), electrocardiography (ECG), motion tracking data are collected and the surgery is documented by photos (1 photo/per second). Additionally, perceived physical discomfort (frequency and intensity) and mental load will be assessed within certain time intervals and at the very end of the surgery. The surgeon will not be disturbed in his actions and movement by the measurement equipment or applied procedures. Previous studies with similar designs can be seen as references in this context (549/2012BO1, 409/2013BO1, 262/2018BO1). After completing the surgery, the surgeon will rate difficulty of the surgery, work precision, eye strain and ergonomics during the surgery. Routine interventions like hysterectomies and other selected indications will be analyzed.
- Conditions
- Musculoskeletal Diseases or Conditions
- Being tested
- Robotically Assisted Laparoscopic Surgery, Conventional Laparoscopic Surgery
- Keywords
- Muscular and mental demand, physical discomfort, eye strain
- Medical subject headings
- Musculoskeletal Diseases, Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotically Assisted Laparoscopic SurgeryProcedure or surgery
robotically assisted surgeries of about 60-minute duration with additional 30 min for preparing with the measurement equipment before surgery and 15 post evaluation of the corresponding surgery
Conventional Laparoscopic SurgeryProcedure or surgery
conventional surgeries of about 60-minute duration with additional 30 min for preparing with the measurement equipment before surgery and 15 post evaluation of the corresponding surgery
| Study group | Role | What they receive |
|---|---|---|
| Robotically Assisted Laparoscopy | Surgeons perform robot-assisted laparoscopic surgery Receives: Procedure: Robotically Assisted Laparoscopic Surgery | |
| Conventional Laparoscopy | Surgeons perform conventional laparoscopic surgery Receives: Procedure: Conventional Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activity of the bilateral trapezius pars descendens muscle
The muscle activity of the bilateral trapezius pars descendens muscle will be assessed using surface electromyography, with the root-mean-square (RMS) of electrical muscle activity recordings measured through bipolar surface electrodes. Data will be normalized to an isometric voluntary maximum electrical activation (MVE).
Measured: during surgery
Secondary outcomes (8)
Muscle activity of the bilateral forearm muscles
The muscle activity of the bilateral forearm muscles will be assessed using surface electromyography, with the root-mean-square (RMS) of electrical muscle activity recordings measured through bipolar surface electrodes. Data will be normalized to an isometric voluntary maximum electrical activation (MVE).
Measured: during surgery
Kinematics
For kinematics, the outcome measures involve the assessment of shoulder abduction, trunk, and head flexion angles in degrees, which are determined using gravimetric position sensors, providing precise measurements of body positioning during the task.
Measured: during surgery
Perceived physical discomfort
Perceived physical discomfort is evaluated by assessing its frequency and intensity. Frequency indicates the number of occurrences, while intensity is measured on a 0 to 10 scale, where higher values indicate more intense discomfort. These measurements are recorded at 20-minute intervals to monitor changes in discomfort over time.
Measured: during surgery
Perceived mental demand
Perceived mental demand is evaluated using the NASA (National Aeronautics and Space Administration ) Task Load Index (TLX) questionnaire's mental demand dimension, providing a subjective score ranging from 0 to 21, reflecting the perceived cognitive load during the task. Higher values are representing higher perceived mental demand.
Measured: during surgery
Perceived mental demand - Heart rate
Heart rate (beats per minute) and heart rate variability, such as SDNN (standard deviation of the beat-to-beat differences in instantaneous heart rate), are recorded via electrocardiography to quantify physiological responses associated with mental demand.
Measured: during surgery
Perceived mental demand - Heart rate variability
Heart rate variability, to be precise SDNN (standard deviation of the beat-to-beat differences in instantaneous heart rate), are recorded via electrocardiography to quantify physiological responses associated with mental demand.
Measured: during surgery
Work precision
Work precision is measured during surgery using a visual analogue scale ranging from 0 to 100 mm, providing an indication of the precision and accuracy of the surgical maneuvers performed.
Measured: during surgery
Eye strain
Eye strain is evaluated using a 10-item questionnaire designed to assess the severity of eye strain, with each question scored on a scale from 0 to 6, aiding in the comprehensive understanding of the subjective experience of visual discomfort.
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Jun 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal Diseases or ConditionsStudies 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
- 4 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
- Benjamin Steinhilber, PD Dr., Principal investigator, Institute of Occupational and Social Medicine and Health Services ResearchBernhard Krämer, Prof. Dr., Principal investigator, University Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109753
- Sponsor's protocol ID
- MT_ASENSUS SOS
- Acronym
- ERCON
- Status last verified
- Jan 2026
- First submitted
- 10 Oct 2023
- Last updated
- 28 Jan 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ergonomic Benefits From Robotically Assisted Laparoscopy for Hysterectomies and Other Selected Indications in Comparison to Conventional Laparoscopy - an Explorative Study
- ClinicalTrials.gov ID
- NCT06109753
- Acronym / sponsor ID
- ERCON / MT_ASENSUS SOS
- Conditions
- Musculoskeletal Diseases or Conditions
- Keywords
- Muscular and mental demand, physical discomfort, eye strain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 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 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 31 Oct 2023 (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.
This is a prospective, single-center, observational clinical trial at the Department of Women's Health of the University Hospital Tübingen.
Detailed description
Monocentric trial to evaluate differences in musculoskeletal and cognitive demands of robot-assisted laparoscopic surgery (RALS) vs. conventional laparoscopic surgery (CLS). Demographic and personal data are collected and pseudonymized. During surgery surface electromyography (EMG), electrocardiography (ECG), motion tracking data are collected and the surgery is documented by photos (1 photo/per second). Additionally, perceived physical discomfort (frequency and intensity) and mental load will be assessed within certain time intervals and at the very end of the surgery. The surgeon will not be disturbed in his actions and movement by the measurement equipment or applied procedures. Previous studies with similar designs can be seen as references in this context (549/2012BO1, 409/2013BO1, 262/2018BO1). After completing the surgery, the surgeon will rate difficulty of the surgery, work precision, eye strain and ergonomics during the surgery. Routine interventions like hysterectomies and other selected indications will be analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotically Assisted Laparoscopy | – | Procedure: Robotically Assisted Laparoscopic SurgerySurgeons perform robot-assisted laparoscopic surgery |
| Conventional Laparoscopy | – | Procedure: Conventional Laparoscopic SurgerySurgeons perform conventional laparoscopic surgery |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 4 (males and females) gynecological surgeons
Key inclusion criteria (4 listed)
- Age between 18 and 68 years
- surgeons that are able to work in full shift
- trained surgeons in RALS and CLS
- written informed consent
Key exclusion criteria (4 listed)
- persons influenced by analgesics or muscle relaxants
- persons not able to perform their common work for any reason
- persons with acute diseases
- muscle injury
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 |
|---|---|---|
| Robotically Assisted Laparoscopic Surgeryrobotically assisted surgeries of about 60-minute duration with additional 30 min for preparing with the measurement equipment before surgery and 15 post evaluation of the corresponding surgery | Procedure or surgery | Robotically Assisted Laparoscopy |
| Conventional Laparoscopic Surgeryconventional surgeries of about 60-minute duration with additional 30 min for preparing with the measurement equipment before surgery and 15 post evaluation of the corresponding surgery | Procedure or surgery | Conventional Laparoscopy |
Primary outcome
Muscle activity of the bilateral trapezius pars descendens muscle
Time frame: during surgery
The muscle activity of the bilateral trapezius pars descendens muscle will be assessed using surface electromyography, with the root-mean-square (RMS) of electrical muscle activity recordings measured through bipolar surface electrodes. Data will be normalized to an isometric voluntary maximum electrical activation (MVE).
8 secondary outcomes
Muscle activity of the bilateral forearm muscles
Time frame: during surgery
Kinematics
Time frame: during surgery
Perceived physical discomfort
Time frame: during surgery
Perceived mental demand
Time frame: during surgery
Perceived mental demand - Heart rate
Time frame: during surgery
Perceived mental demand - Heart rate variability
Time frame: during surgery
Work precision
Time frame: during surgery
Eye strain
Time frame: during surgery
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 28 Jan 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.
Benjamin Steinhilber, PD Dr. principal investigator
Institute of Occupational and Social Medicine and Health Services Research
Bernhard Krämer, Prof. Dr. principal investigator
University Women's Hospital
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 Musculoskeletal Diseases or Conditions, 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 4 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 28 Jan 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?
Muscle activity of the bilateral trapezius pars descendens muscle (time frame: during surgery). 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 28 Jan 2026.