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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00311285
• Other study ID #: BB-001-G-2006
• Status: Not yet recruiting
• Phase: N/A
• First received: April 3, 2006
• Last updated: June 28, 2007
• Est. completion date: March 2007

Study information

• Verified date: March 2006
• Source: University Hospital, Gentofte, Copenhagen
• Contact: Helga R Munch-Petersen, MD
• Phone: +45 39 77 33 99
• Email: hemupe04[@]gentoftehosp.kbhamt.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy doctors

Exclusion Criteria:

• Pregnancy

• Left handed

• Endocrine disease

• Cardiac rhythm disturbances

• History of recent injury in shoulder/arms

Study Design

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

Related Conditions & MeSH terms

• Stress

Intervention

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

Locations

Country	Name	City	State
Denmark	UHGentofte	Hellerup
Denmark	UHGentofte	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EMG
Primary	Goniometry
Primary	Inclinometry
Primary	HRV
Primary	Salivary Cortisol