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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:
Medtronic - MITG
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
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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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
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 
Overall Participants Analyzed 
[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 ]

2.  Secondary:   Histologic Evidence of Burn at the Umbilical 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
This is a pilot study with no funding so data is limited.


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


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


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

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