Trial document




drksid header

  DRKS00008758

Trial Description

start of 1:1-Block title

Title

Evaluation of an arm support system based on simulated laparoscopic procedures

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Surgeons performing laparoscopic surgery have physical stress and associated helath problems in the shoulder-neck region. Therefore an arm-support-system to reduce physical stress has been developed, which will now be evaluated.
Surgeons from gynecology and urology will participate in the study.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Laparoscopic surgery induces physical stress to the surgeon that is associated with an increased
prevalence of musculoskeletal pain and injury in the shoulder-neck region. The present study aims to investigate the effects and usability of a new arm-support-system. It is hypothesized that the arm-support-system reduces muscular strain in the shoulder neck region and does not impair working pace and precision. Evaluation will take place on preclinical platform. Experienced surgeon in laparoscopy from gynecology and urology will participate in this study and perform simulated laparoscopic procedures using a pelvitrainer with and without the arm-support-system.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00008758
  •   2015/07/03
  •   [---]*
  •   yes
  •   Approved
  •   251/2015BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   increased static muscle strain
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   simulated laparoscopic procedures with totally relief of the arms (90% arm weight) by the arm-support-system.
  •   simulated laparoscopic procedures with partly relief of the arms (50% arm weight) by the arm-support-system.
  •   simulated laparoscopic procedures without the arm-support-system (control measurement)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Crossover
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

primary outcome: muscle strain of the trapezius pars descendens muscle. Muscle strain will be quantified using the electrical activity measured by bipolar surface electromyography

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

work pace, precision, Posture of the upper arm, poster of the upper body, movement pattern of the right arm, subjective rating of strain

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2015/07/10
  •   20
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

healthy subjects, subjects that are able to give their written consent after detailed information about the study contents and aims; surgeons performing laparoscopy during their daily work

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

people under drug abuse, analgetica or muscle relaxants, people that are not able to work for the whole working day, people suffering from acute disease or pain; acute muscle injury; dependent on the level of limitation people with diseaes of the spine, hand-arm-system, muscles, neuro-psychological diseases, relieving posture, and other diseaeses will be excluded; elevated bloodpressure (RR>160 systolic/>100 diastolic mmHg);

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Tübingen, Institut für Arbeitsmedizin, Sozialmedizin und Versorgungsforschung
    • Mr. 
    • Wilhelmstraße 27
    • 72074  Tübingen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   07071-29-86805
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Institut für Konstruktionstechnik und Technisches Design, Universität Stuttgart
    • Pfaffenwaldring 0
    • 70569  Stuttgart
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Institut für Systemdynamik
    • Waldburgstraße 17/19
    • 70563  Stuttgart
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Klinik für Urologie, Universitätsklinikum Tübingen
    • Hoppe-Seyler-Str. 3
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Universitäts-Frauenklinik, Universitätsklinikum Tübingen
    • Calwerstraße 7
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Institut für Arbeitsmedizin, Sozialmedizin und Versorgungsforschung
    • Mr.  Dr. rer. nat.  Benjamin  Steinhilber 
    • Wilhelmstraße 27
    • 72074  Tübingen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Institut für Arbeitsmedizin, Sozialmedizin und Versorgungsforschung
    • Mr.  Benjamin  Steinhilber 
    • Wilhelmstraße 27
    • 72074  Tübingen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Ministerium für Wissenschaft, Forschung und Kunst Baden-Württemberg
    • Königsstraße 46
    • 70173  Stuttgart
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Festo AG & Co. KG
    • Ruiter Straße 82
    • 73734  Esslingen
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
  • start of 1:1-Block address otherSupport
    • Trumpf Medizin Systeme GmbH + Co. KG
    • Carl-Zeiss-Straße 7-9
    • 07318  Saalfeld
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
  • start of 1:1-Block address otherSupport
    • Dekanat der Medizinischen Fakultät, Universitätsklinikum Tübingen
    • Calwerstrasse 5
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
  • start of 1:1-Block address otherSupport
    • Fakultät für Maschinenbau, Universität Stuttgart
    • Pfaffenwaldring 9
    • 70569  Stuttgart
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.