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
  Purpose

Electrosurgery is used in virtually every laparoscopic operation performed. Capacitive coupling is a common electrosurgery complication. Previous work biopsying the skin adjacent to laparoscopic port sites is a method to determine if capacitive coupling thermal injury to the skin occurs during a laparoscopic operation. [Willson et al. Surg Endosc (1997) 11:653] In our previous study, COMIRB 09-0049, we found thermal injury at 55% of umbilical trocar site skin biopsies and 35% of epigastric trocar site skin biopsies following laparoscopic cholecystectomy. Our benchtop research compared bundling of the camera cord with the active electrode cord versus unbundling of the camera cord with the active electrode cord and found a 59% decrease in heat generated in the unbundling experimental set-up. [Jones, EL, Robinson, TN, et al. Surg Endosc (2012) Epub.]

This study plans to compare thermal injury which occurs during two commonly used operating room set-ups. First, laparoscopic cholecystectomy with bundled camera/active electrode cords. And second, laparoscopic cholecystectomy with unbundled camera/active electrode cords. The primary outcome is the incidence of thermal injury at the skin adjacent to the camera port site (the umbilical port) that will be diagnosed by histology.


Condition Intervention
Fatigue
Other: Unbundling of cords
Other: Bundling of cords

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Bundling and Unbundling the Laparoscopic Electrosurgery Cord With the Camera Cord: A Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Histologic Thermal Injury to Umbilical Port Site Skin [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at these port sites.


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


Enrollment: 84
Study Start Date: September 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bundling of cords
The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.
Other: Bundling of cords
The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.
Experimental: 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
Other: 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients undergoing urgent or emergent laparoscopic cholecystectomy operations
  • Patients younger than 18
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01707095

Locations
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Thomas N Robinson, MD University of Colorado, Denver
  More Information

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

Keywords provided by University of Colorado, Denver:
Electrosurgery
Radiofrequency energy
Monopolar instruments
Capacitive coupling
Thermal injury
Surgical complications

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014