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
|Condition or disease||Intervention/treatment||Phase|
|Stress||Device: Electrogram (EMG), heart rate variability (HRV), salivary cortisol, goniometry, inclinometry||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|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|
|Study Completion Date :||March 2007|
- Salivary Cortisol
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
|Contact: Helga R Munch-Petersen, MD||+45 39 77 33 firstname.lastname@example.org|
|Contact: Jacob Rosenberg, MD||+ 45 39 77 33 email@example.com|
|Hellerup, Denmark, 2100|
|UHGentofte||Not yet recruiting|
|Hellerup, Denmark, 2900|
|Principal Investigator: Helga R Munch-Petersen, MD|
|Principal Investigator:||Helga R Munch-Petersen, MD||University Hospital, Gentofte, Copenhagen|