Bundling and Unbundling the Laparoscopic Electrosurgery Cord With the Camera Cord

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01707095
First received: September 21, 2012
Last updated: July 3, 2014
Last verified: July 2014
Results First Received: May 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor)
Condition: Fatigue
Interventions: Other: Unbundling of cords
Other: Bundling of cords

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Bundled Active electrode cord and camera cord parallel
Unbundled / Separated Active electrode cord and camera cord separated

Participant Flow:   Overall Study
    Bundled     Unbundled / Separated  
STARTED     42     42  
COMPLETED     42     42  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Bundling of Cords

The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.

Bundling of cords: The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.

Unbundling of Cords

The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another

Unbundling of cords: The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another

Total Total of all reporting groups

Baseline Measures
    Bundling of Cords     Unbundling of Cords     Total  
Number of Participants  
[units: participants]
  42     42     84  
Age  
[units: years]
Mean ± Standard Deviation
  44  ± 15     44  ± 18     44  ± 17  
Gender  
[units: participants]
     
Female     37     32     69  
Male     5     10     15  
Region of Enrollment  
[units: participants]
     
United States     42     42     84  



  Outcome Measures
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1.  Primary:   Histologic Thermal Injury to Umbilical Port Site Skin   [ Time Frame: 1 day ]

2.  Secondary:   Histologic Evidence of Burn at the Epigastric Port Site Skin.   [ Time Frame: 1 day ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Thomas Robinson
Organization: University of Colorado
phone: 303-724-2728
e-mail: thomas.robinson@ucdenver.edu


Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01707095     History of Changes
Other Study ID Numbers: 12-0906
Study First Received: September 21, 2012
Results First Received: May 27, 2014
Last Updated: July 3, 2014
Health Authority: United States: Institutional Review Board