Physical and Mental Load in the Surgeon Performing Laparoscopic Tasks
Recruitment status was: Not yet recruiting
Device: Electrogram (EMG), heart rate variability (HRV), salivary cortisol, goniometry, inclinometry
|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|
- Salivary Cortisol
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311285
|Hellerup, Denmark, 2100|
|Hellerup, Denmark, 2900|
|Principal Investigator:||Helga R Munch-Petersen, MD||University Hospital, Gentofte, Copenhagen|