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

NCT04352452 | Completed

• 1 other identifier: MT_SOS II
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Excessive Musculoskeletal Stress

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

• Median muscular load of the bilateral extensor digitorum and flexor carpi radials muscles

  75 Minutes

• Static muscular load of the bilateral extensor digitorum and flexor carpi radials muscles

  75 Minutes

• sustained muscular activity of the bilateral extensor digitorum and flexor carpi radials muscles

  75 Minutes

• Muscular rest time of the bilateral extensor digitorum and flexor carpi radials muscles

  75 Minutes

• Shoulder abduction angle [degree]

  75 Minutes

Other Outcomes (5)

• Body height [cm]

  5 Minutes

• Body weight [kg]

  5 Minutes

• Physical activity [hours of sports per week]

  5 Minutes

Study Arms (2)

RALS

Surgeons perform robot-assisted laparoscopic surgery

Procedure: laparoscopic surgery

CLS

Surgeons perform conventional laparoscopic surgery

Procedure: laparoscopic surgery

Interventions

laparoscopic surgery PROCEDURE

differences in musculoskeletal and cognitive stress

CLS; RALS

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age between 18 and 68 years
• Able to work in full shift
• trained surgeons in RALS and CLS
• written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Institute of Occupational and Social Medicine and Health Services Research, Tuebingen: collaborator

Study Sites (1)

University Hospital Tuebingen, Department of Women's Health

Tübingen, 72076, Germany

Location

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sara Brucker, Prof. Dr.

  Department of Women's Health, University Hospital Tuebingen

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: April 20, 2020
• Study Start: June 1, 2019
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 10, 2026

Record last verified: 2022-11

Locations

DE (1)