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| Sponsored by: |
University Hospital, Gentofte, Copenhagen |
| Information provided by: | University Hospital, Gentofte, Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00311285 |
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: | Other, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Physical and Mental Load During Laparoscopic Tasks. A Prospective Randomized Trial of the Ergonomics in a Black Box Model |
| Estimated Enrollment: | 12 |
| Estimated Study Completion Date: | March 2007 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
| Denmark | |||||
| UHGentofte | |||||
| Hellerup, Denmark, 2100 | |||||
| Principal Investigator: Helga R Munch-Petersen, MD | |||||
| UHGentofte | Not yet recruiting | ||||
| Hellerup, Denmark, 2900 | |||||
| Principal Investigator: Helga R Munch-Petersen, MD | |||||
| University Hospital, Gentofte, Copenhagen |
| Principal Investigator: | Helga R Munch-Petersen, MD | University Hospital, Gentofte, Copenhagen |
More Information
| Study ID Numbers: | BB-001-G-2006 |
| First Received: | April 3, 2006 |
| Last Updated: | June 28, 2007 |
| ClinicalTrials.gov Identifier: | NCT00311285 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
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