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

U

University Hospital Tuebingen

Status

Completed

Conditions

Excessive Musculoskeletal Stress

Treatments

Procedure: laparoscopic surgery

Study type

Observational

Funder types

Other

Identifiers

NCT04352452
MT_SOS II

Details and patient eligibility

About

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

Enrollment

5 patients

Sex

All

Ages

18 to 68 years old

Volunteers

No Healthy Volunteers

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

Trial design

5 participants in 2 patient groups

RALS
Description:
Surgeons perform robot-assisted laparoscopic surgery
Treatment:
Procedure: laparoscopic surgery
CLS
Description:
Surgeons perform conventional laparoscopic surgery
Treatment:
Procedure: laparoscopic surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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