An observational study in Musculoskeletal Diseases or Conditions, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to participants aged 18 Years to 68 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by University Hospital Tuebingen · Observational
This is a prospective, single-center, observational clinical trial at the Department of Women's Health of the University Hospital Tübingen.
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.
752 studies on the registry are indexed under Musculoskeletal Diseases; 164 are open to participants now.
This study's enrollment of 4 is below the median of 120 across 207 observational studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →University Hospital Tuebingen is the lead sponsor of 490 studies on the registry; 108 are open to participants now.
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4 (males and females) gynecological surgeons
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Surgeons perform robot-assisted laparoscopic surgery
Procedure: Robotically Assisted Laparoscopic Surgery
Surgeons perform conventional laparoscopic surgery
Procedure: Conventional Laparoscopic 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 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
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).
Time frame: during surgery
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: during surgery
Musculoskeletal complaints
The Nordic Questionnaire encompasses an evaluation of diverse parameters, including body height (measured in centimeters), body weight (measured in kilograms), physical activity (assessed in hours of sports per week), work experience (measured in years), and the presence of musculoskeletal complaints within the last 12 months, along with point prevalence \[n\]. This holistic assessment offers critical insights into the participants' physical condition and occupational health status. Additionally, please note that the Nordic Questionnaire does not specifically employ a single scale; rather, it utilizes various metrics tailored to the different parameters, and thus, the measurement scales can differ based on the specific parameter being assessed.
Time frame: within the last 12 months
Duration of the surgical procedure
The duration of the surgical procedure is a critical outcome measure, recorded in minutes, providing a precise indication of the time taken to complete the specific surgical intervention, aiding in the assessment of surgical efficiency and time management.
Time frame: 105 Minutes
Difficulty of the surgery
The perceived difficulty of the surgery is measured using a visual analogue scale ranging from 0 to 100 mm, with 0 indicating that the surgery was not difficult and 100 indicating that the surgery was very difficult. This measure allows the surgeons to subjectively express the complexity and challenges associated with the performed surgical procedure.
Time frame: 5 Minutes
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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