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

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ClinicalTrials.gov Identifier: NCT01664806
Recruitment Status : Completed
First Posted : August 14, 2012
Results First Posted : March 1, 2013
Last Update Posted : March 25, 2013
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:

Monopolar radiofrequency energy is used to perform the laparoscopic cholecystectomy operation. The appearance of burns are common following laparoscopic cholecystectomy; particularly at the port site of the active electrode. Willson et al found that 9 out of 19 skin biopsies from the skin adjacent to the port site of the monopolar instrument's active electrode were found to have thermal injury by histology. [Willson et al. Surg Endosc (1997) 11:653] Authors have speculated that using different generator modes may lead to less capacitive coupling; [Wu et al Am J Surg (2000) 179: 67] although no data exists to support these speculations.

The investigators hypothesize that capacitive coupling electrosurgical injuries from monopolar instruments are occurring during laparoscopic cholecystectomy operations. The investigators hypothesize that use of blend modes will reduce the incidence of capacitive coupling thermal injuries during laparoscopic operations in comparison to coag modes.


Condition or disease Intervention/treatment Phase
Intraoperative Complications Thermal Injury Electrocoagulation Device: Covidien Triad monopolar generator Phase 3

Detailed Description:

SPECIFIC AIM:

Compare incidence of skin burns caused by using coag versus blend monopolar instrument modes at the active electrode port site (epigastric port), and at the non-active electrode port sites (umbilical and right abdominal wall).

OUTCOME MEASURE:

Histologic evidence of thermal injury at the skin biopsy sites of the active electrode port, the camera port and the medial assistant port. Histology will be performed by a blinded pathologist.

POPULATION TO BE ENROLLED:

Subjects undergoing elective laparoscopic cholecystectomy will be recruited in the principle investigators pre-operative clinic. All subjects will be 18 years and older.

STUDY DESIGN AND METHODS:

Written informed consent will be obtained in all subjects prior to enrollment. Subjects will be randomized on the day of surgery to undergo the laparoscopic cholecystectomy operation with either the coag or blend modes of using standard monopolar electrosurgery instruments. The randomization process will occur by using a random number generator. A total of 40 subjects will be recruited; 20 subjects per group. Shave skin biopsies will be performed at the edge of the incisions of the active electrode port, the camera port and the medial assistant port on the right abdominal wall. The incisions and skin will be otherwise opened and closed in the routine clinical manor.

STATISTICAL ANALYSIS The incidence of skin burns created using coag or blend modes will be compared individually at all three port sites using chi-squared or Fisher's exact test where appropriate. Baseline demographic data (e.g., gender, age, body mass index, operation time, blood loss, indication for operation and histology) will be compared in the two groups.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode and Thermal Injury to Tissue Adjacent to Port Sites
Study Start Date : November 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Coag mode 30 Watts Power
Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.
Experimental: Covidien Triad monopolar generator
Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform Elective laparoscopic cholecystectomy. which is the experimental arm of the study's mode.
 Device: Covidien Triad monopolar generator
Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.


Outcome Measures
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Primary Outcome Measures :
  1. Histologic Thermal Injury to Epigastric Port Site Skin [ Time Frame: 1 day ]
    Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at this port sites.


Secondary Outcome Measures :
  1. Histologic Evidence of Burn at the Umbilical Port Site Skin [ Time Frame: 1 day ]
    Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port site.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 years and older planned to undergo elective laparoscopic cholecystectomy

Exclusion Criteria:

  • Patients undergoing urgent or emergent laparoscopic cholecystectomy operations
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01664806


Locations
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United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Medtronic - MITG
Investigators
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Principal Investigator: Thomas Robinson, MD University of Colorado, Denver
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01664806    
Other Study ID Numbers: 09-0049
First Posted: August 14, 2012    Key Record Dates
Results First Posted: March 1, 2013
Last Update Posted: March 25, 2013
Last Verified: March 2013
Keywords provided by University of Colorado, Denver:
Electrosurgery
Radiofrequency energy
Monopolar instruments
 Capacitive coupling
Thermal injury
Surgical complications
Additional relevant MeSH terms:
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Intraoperative Complications
Wounds and Injuries
Burns
Pathologic Processes