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Status unknownNCT00311285Updated Jul 2, 2007

Physical and Mental Load in the Surgeon Performing Laparoscopic Tasks

An interventional study of Electrogram (EMG), heart rate variability (HRV), salivary cortisol, goniometry, inclinometry in Stress, sponsored by University Hospital, Gentofte, Copenhagen. Status unknown at 2 sites in Denmark. Open to participants aged 22 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-07-02.

Sponsored by University Hospital, Gentofte, Copenhagen · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Mar 2006), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
22 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stress

Keywords

  • Electromyography
  • Glucocorticoids
  • Heart Rate
  • Physical workload
  • Mental workload
  • Ergonomics
  • Laparoscopy
  • Workload
  • Biomechanics
03

In context

Lead sponsor

University Hospital, Gentofte, Copenhagen is the lead sponsor of 161 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy doctors

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Left handed
  • Endocrine disease
  • Cardiac rhythm disturbances
  • History of recent injury in shoulder/arms
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Interventions

  • DeviceElectrogram (EMG), heart rate variability (HRV), salivary cortisol, goniometry, inclinometry
06

What researchers measure

Primary outcomes

  1. EMG

  2. Goniometry

  3. Inclinometry

  4. HRV

  5. Salivary Cortisol

07

Study locations

2 sites
  • UHGentofte
    Hellerup, 2100, Denmark
  • UHGentofte
    Hellerup, 2900, Denmark
    • Helga R Munch-Petersen, MD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00311285
First posted
Apr 5, 2006
Completion
Mar 2007
Last update
Jul 2, 2007

Study contacts

Helga R Munch-Petersen, MD
Contact
hemupe04@gentoftehosp.kbhamt.dk
+45 39 77 33 99
Jacob Rosenberg, MD
Contact
jaro@gentoftehosp.kbhamt.dk
+ 45 39 77 33 65
Helga R Munch-Petersen, MD
principal investigator · University Hospital, Gentofte, Copenhagen
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2006. You cannot join it, but the record below documents what was studied.

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