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Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode Causing Thermal Injury at Port Site Skin

This study has been completed.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01664806
First received: August 10, 2012
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
Results First Received: January 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Basic Science
Conditions: Intraoperative Complications
Thermal Injury
Electrocoagulation
Intervention: Device: Covidien Triad monopolar generator

  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
40 patients were recruited at the University of Colorado Hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two screened patients were excluded because they refused entry into the trial.

Reporting Groups
  Description
Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts

Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.

Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.
Coag Mode 30 Watts Power

Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.

Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy

Participant Flow:   Overall Study
    Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts     Coag Mode 30 Watts Power  
STARTED     20     20  
COMPLETED     20     20  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts

Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.

Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.
Coag Mode 30 Watts Power

Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.

Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy
Total Total of all reporting groups

Baseline Measures
    Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts     Coag Mode 30 Watts Power     Total  
Number of Participants  
[units: participants]
 		  20     20     40  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     18     19     37  
>=65 years     2     1     3  
Age  
[units: years]
Mean ± Standard Deviation 		  47  ± 18     41  ± 12     44  ± 15  
Gender  
[units: participants]
 		     
Female     16     15     31  
Male     4     5     9  
Region of Enrollment  
[units: participants]
 		     
United States     20     20     40  



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

2.  Secondary:   Histologic Evidence of Burn at the Umbilical Port Site Skin   [ Time Frame: 1 day ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
This is a pilot study with no funding so data is limited.  


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


No publications provided


Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01664806     History of Changes
Other Study ID Numbers: 09-0049
Study First Received: August 10, 2012
Results First Received: January 25, 2013
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board