Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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.
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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