Viewing Study NCT00311285



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Study NCT ID: NCT00311285
Status: UNKNOWN
Last Update Posted: 2007-07-02
First Post: 2006-04-03

Brief Title: Physical and Mental Load in the Surgeon Performing Laparoscopic Tasks
Sponsor: University Hospital Gentofte Copenhagen
Organization: University Hospital Gentofte Copenhagen

Study Overview

Official Title: Physical and Mental Load During Laparoscopic Tasks A Prospective Randomized Trial of the Ergonomics in a Black Box Model
Status: UNKNOWN
Status Verified Date: 2006-03
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None