NCT00311285

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

July 2, 2007

Status Verified

March 1, 2006

First QC Date

April 3, 2006

Last Update Submit

June 28, 2007

Conditions

Stress

Keywords

ElectromyographyGlucocorticoidsHeart RatePhysical workloadMental workloadErgonomicsLaparoscopyWorkloadBiomechanics

Outcome Measures

Primary Outcomes (5)

  • EMG

  • Goniometry

  • Inclinometry

  • HRV

  • Salivary Cortisol

Interventions

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

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy doctors

You may not qualify if:

  • Pregnancy
  • Left handed
  • Endocrine disease
  • Cardiac rhythm disturbances
  • History of recent injury in shoulder/arms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UHGentofte

Hellerup, 2100, Denmark

Location

UHGentofte

Hellerup, 2900, Denmark

Location

MeSH Terms

Interventions

Electromyography

Intervention Hierarchy (Ancestors)

ElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyography

Study Officials

  • Helga R Munch-Petersen, MD

    University Hospital, Gentofte, Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helga R Munch-Petersen, MD

CONTACT

+45 39 77 33 99hemupe04@gentoftehosp.kbhamt.dk

Jacob Rosenberg, MD

CONTACT

+ 45 39 77 33 65jaro@gentoftehosp.kbhamt.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 5, 2006

Study Completion

March 1, 2007

Last Updated

July 2, 2007

Record last verified: 2006-03

Locations

DK(2)