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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00311285
Other study ID # BB-001-G-2006
Secondary ID
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
Est. primary completion date
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


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
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