Physical and Mental Load in the Surgeon Performing Laparoscopic Tasks

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by University Hospital, Gentofte, Copenhagen.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00311285
First received: April 3, 2006
Last updated: June 28, 2007
Last verified: March 2006
  Purpose

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 Intervention
Stress
Device: Electrogram (EMG), heart rate variability (HRV), salivary cortisol, goniometry, inclinometry

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Physical and Mental Load During Laparoscopic Tasks. A Prospective Randomized Trial of the Ergonomics in a Black Box Model

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • EMG
  • Goniometry
  • Inclinometry
  • HRV
  • Salivary Cortisol

Estimated Enrollment: 12
Estimated Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   22 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00311285     History of Changes
Other Study ID Numbers: BB-001-G-2006
Study First Received: April 3, 2006
Last Updated: June 28, 2007
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on July 28, 2014