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Physical and Mental Load in the Surgeon Performing Laparoscopic Tasks

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ClinicalTrials.gov Identifier: NCT00311285
Recruitment Status : Unknown
Verified March 2006 by University Hospital, Gentofte, Copenhagen.
Recruitment status was:  Not yet recruiting
First Posted : April 5, 2006
Last Update Posted : July 2, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
The surgeons load during laparoscopic surgery is still unclear. Laparoscopic surgery is more demanding because of the challenge of operating through small scars in the abdominal wall without any tactile feedback depending only on the visual feedback on a monitor. The purpose is to establish a model of how to measure mental and physical load in laparoscopy.

Condition or disease Intervention/treatment
Stress Device: Electrogram (EMG), heart rate variability (HRV), salivary cortisol, goniometry, inclinometry

Detailed Description:

The surgeons load during laparoscopic surgery is still unclear. Laparoscopic surgery is more demanding because of the challenge of operating through small scars in the abdominal wall without any tactile feedback depending only on the visual feedback on a monitor. Most studies have been conducted in laboratory set-ups: Black Box.

This study will establish a model of how to measure the biomechanical loads at muscular, joint and postural level, as well as measuring stress-hormone and cardiac rhythm. The study is a precursor of ergonomic studies performed inside the operating room. Advanced operating rooms designed specially for laparoscopy have been introduced in many departments. We do not know if they are more ergonomically correct. We will simulate laparoscopic tasks in an operating room. The hypothesis is that a traditional laparoscopic set-up is more demanding than a set-up mimicking an advanced operating room.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Physical and Mental Load During Laparoscopic Tasks. A Prospective Randomized Trial of the Ergonomics in a Black Box Model
Estimated Study Completion Date : March 2007
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. EMG
  2. Goniometry
  3. Inclinometry
  4. HRV
  5. Salivary Cortisol

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy doctors

Exclusion Criteria:

  • Pregnancy
  • Left handed
  • Endocrine disease
  • Cardiac rhythm disturbances
  • History of recent injury in shoulder/arms
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311285


Contacts
Contact: Helga R Munch-Petersen, MD +45 39 77 33 99 hemupe04@gentoftehosp.kbhamt.dk
Contact: Jacob Rosenberg, MD + 45 39 77 33 65 jaro@gentoftehosp.kbhamt.dk

Locations
Denmark
UHGentofte
Hellerup, Denmark, 2100
UHGentofte Not yet recruiting
Hellerup, Denmark, 2900
Principal Investigator: Helga R Munch-Petersen, MD         
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Helga R Munch-Petersen, MD University Hospital, Gentofte, Copenhagen
More Information

ClinicalTrials.gov Identifier: NCT00311285     History of Changes
Other Study ID Numbers: BB-001-G-2006
First Posted: April 5, 2006    Key Record Dates
Last Update Posted: July 2, 2007
Last Verified: March 2006

Keywords provided by University Hospital, Gentofte, Copenhagen:
Electromyography
Glucocorticoids
Heart Rate
Physical workload
Mental workload
Ergonomics
Laparoscopy
Workload
Biomechanics