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

Excessive Musculoskeletal Stress Clinical Trial

— SOSII  

Official title:

SOS - Save Our Surgeons - Differences in Musculoskeletal and Cognitive Stress of Robot-assisted Laparoscopic Surgery vs. Conventional Laparoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04352452
• Other study ID #: MT_SOS II
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: February 1, 2023

Study information

• Verified date: November 2022
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

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

Related Conditions & MeSH terms

• Excessive Musculoskeletal Stress

Intervention

Procedure:
• laparoscopic surgery
differences in musculoskeletal and cognitive stress

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen, Department of Women's Health	Tuebingen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Institute of Occupational and Social Medicine and Health Services Research, Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body height [cm]	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
Other	Body weight [kg]	The Nordic Questionnaire will be used to determine subjects body weight	5 Minutes
Other	Physical activity [hours of sports per week]	The Nordic Questionnaire will be used to determine subjects weekly physical activity	5 Minutes
Other	work experience [years]	The Nordic Questionnaire will be used to determine subjects work experience	5 Minutes
Other	Musculoskeletal complaints in the last 12 month, last week, and point prevalence [n]	The Nordic Questionnaire will be used to determine subjects musculoskeletal complaints in the last 12 month, last week, and point prevalence	5 Minutes
Primary	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]	75 Minutes
Primary	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.	75 Minutes
Primary	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.	75 Minutes
Primary	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.	75 Minutes
Secondary	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]	75 Minutes
Secondary	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.	75 Minutes
Secondary	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.	75 Minutes
Secondary	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.	75 Minutes
Secondary	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.	75 Minutes
Secondary	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.	75 Minutes
Secondary	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.	75 Minutes
Secondary	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]	75 Minutes
Secondary	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].	75 Minutes
Secondary	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	75 Minutes
Secondary	heart rate [beats per minute]	Heart rate will be recorded by a one channel electrocardiogram	75 Minutes
Secondary	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	75 Minutes
Secondary	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	75 Minutes