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

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: Completed
• Conditions: Excessive Musculoskeletal Stress
• Intervention / Treatment: Procedure: laparoscopic surgery

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

• Study Contact: Name: Sara Brucker, MD; Phone Number: 82211 +49 7071 29; Email: sara.brucker@med.uni-tuebingen.de

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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

How is the study designed?

Design Details

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
heart rate [beats per minute]	Heart rate will be recorded by a one channel electrocardiogram	75 Minutes
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Body weight [kg]	The Nordic Questionnaire will be used to determine subjects body weight	5 Minutes
Physical activity [hours of sports per week]	The Nordic Questionnaire will be used to determine subjects weekly physical activity	5 Minutes
work experience [years]	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]	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

• Sponsor: University Hospital Tuebingen
• Collaborators: Institute of Occupational and Social Medicine and Health Services Research, Tuebingen
• Investigators: Study Chair: Sara Brucker, Prof. Dr., Department of Women's Health, University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID 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