Physical and Mental Load in the Surgeon Performing Laparoscopic Tasks

Stress Clinical Trial

Official title: Physical and Mental Load During Laparoscopic Tasks. A Prospective Randomized Trial of the Ergonomics in a Black Box Model

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Stress

• NCT number: NCT00311285
• Study type: Interventional
• Source: University Hospital, Gentofte, Copenhagen
• Contact: Helga R Munch-Petersen, MD
• Phone: +45 39 77 33 99
• Email: hemupe04@gentoftehosp.kbhamt.dk
• Status: Not yet recruiting
• Phase: N/A
• Completion date: March 2007