Clinical trial NCT04352452: Save Our Surgeons - Differences in Stress of Robot-assisted Laparoscopic Surgery vs. Conventional Laparoscopic Surgery
Official title: SOS - Save Our Surgeons - Differences in Musculoskeletal and Cognitive Stress of Robot-assisted Laparoscopic Surgery vs. Conventional Laparoscopic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Excessive Musculoskeletal Stress
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Institute of Occupational and Social Medicine and Health Services Research, Tuebingen
First posted: 2020-04-20
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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. 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


Eligibility criteria: 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

Primary outcomes:
measure: Median muscular load of the bilateral trapezius pars descendens muscle surface electromyography.
timeFrame: 75 Minutes
measure: Static muscular load of the bilateral trapezius pars descendens muscle
timeFrame: 75 Minutes
measure: sustained muscular activity of the bilateral trapezius pars descendens muscle
timeFrame: 75 Minutes
measure: Muscular rest time of the bilateral trapezius pars descendens muscle
timeFrame: 75 Minutes
Secondary outcomes:
measure: Median muscular load of the bilateral extensor digitorum and flexor carpi radials muscles
timeFrame: 75 Minutes
measure: Static muscular load of the bilateral extensor digitorum and flexor carpi radials muscles
timeFrame: 75 Minutes
measure: sustained muscular activity of the bilateral extensor digitorum and flexor carpi radials muscles
timeFrame: 75 Minutes
measure: Muscular rest time of the bilateral extensor digitorum and flexor carpi radials muscles
timeFrame: 75 Minutes
measure: Shoulder abduction angle [degree]
timeFrame: 75 Minutes
measure: trunk flexion angle [degree]
timeFrame: 75 Minutes
measure: head flexion angle [degreee]
timeFrame: 75 Minutes
measure: Frequency of perceived physical discomfort [n]
timeFrame: 75 Minutes
measure: Intensity of perceived physical discomfort [0-10; 0 = nothing at all, 10 = extremely high
timeFrame: 75 Minutes
measure: Subjective mental demand [0 - 21; 0 = very low, 21 = very high]
timeFrame: 75 Minutes
measure: heart rate [beats per minute]
timeFrame: 75 Minutes
measure: Heart rate variability as the Standard Deviation of NN intervals [ms]
timeFrame: 75 Minutes
measure: Heart rate variability as the Root Mean Squers of Successive Differences [ms]
timeFrame: 75 Minutes
Other outcomes:
measure: Body height [cm]
timeFrame: 5 Minutes
measure: Body weight [kg]
timeFrame: 5 Minutes
measure: Physical activity [hours of sports per week]
timeFrame: 5 Minutes
measure: work experience [years]
timeFrame: 5 Minutes
measure: Musculoskeletal complaints in the last 12 month, last week, and point prevalence [n]
timeFrame: 5 Minutes
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen, Department of Women's Health
Study officials:
affiliation: Department of Women's Health, University Hospital Tuebingen
name: Sara Brucker, Prof. Dr.
role: STUDY_CHAIR
References: