N/A
N=84
Bundling and Unbundling the Laparoscopic Electrosurgery Cord With the Camera Cord
Fatigue
Bottom Line
View on ClinicalTrials.gov: NCT01707095 ↗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
| Outcome | Result | p-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
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.