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Physical and Mental Load in the Surgeon Performing Laparoscopic Tasks

NCT ID: NCT00311285

Last Updated: 2007-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2007-03-31

Brief Summary

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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

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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.

Conditions

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Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy doctors

Exclusion Criteria

* Pregnancy
* Left handed
* Endocrine disease
* Cardiac rhythm disturbances
* History of recent injury in shoulder/arms
Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Principal Investigators

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Helga R Munch-Petersen, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Gentofte, Copenhagen

Locations

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UHGentofte

Hellerup, , Denmark

Site Status

UHGentofte

Hellerup, , Denmark

Site Status

Countries

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Denmark

Central Contacts

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Helga R Munch-Petersen, MD

Role: CONTACT

[email protected]
+45 39 77 33 99

Jacob Rosenberg, MD

Role: CONTACT

[email protected]
+ 45 39 77 33 65

Other Identifiers

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BB-001-G-2006

Identifier Type: -

Identifier Source: org_study_id