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N/A N=84 Randomized Single-blind

Bundling and Unbundling the Laparoscopic Electrosurgery Cord With the Camera Cord

Fatigue

Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Histologic Thermal Injury to Umbilical Port Site Skin — 24; 13 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Unbundling of cords (Other); Bundling of cords (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Colorado, Denver
Primary completion
Jan 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Histologic Thermal Injury to Umbilical Port Site Skin
24; 13
SECONDARY
Histologic Evidence of Burn at the Epigastric Port Site Skin.
8; 11

Summary

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01707095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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