Fatigue Clinical Trial
Official title:
Bundling and Unbundling the Laparoscopic Electrosurgery Cord With the Camera Cord: A Randomized, Controlled Trial
Verified date | July 2014 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Hospital | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Jones EL, Robinson TN, McHenry JR, Dunn CL, Montero PN, Govekar HR, Stiegmann GV. Radiofrequency energy antenna coupling to common laparoscopic instruments: practical implications. Surg Endosc. 2012 Nov;26(11):3053-7. doi: 10.1007/s00464-012-2312-6. Epub 2012 May 12. — View Citation
Willson PD, van der Walt JD, Moxon D, Rogers J. Port site electrosurgical (diathermy) burns during surgical laparoscopy. Surg Endosc. 1997 Jun;11(6):653-4. — View Citation
Wu MP, Ou CS, Chen SL, Yen EY, Rowbotham R. Complications and recommended practices for electrosurgery in laparoscopy. Am J Surg. 2000 Jan;179(1):67-73. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Histologic Thermal Injury to Umbilical Port Site Skin | 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. | 1 day | Yes |
Secondary | Histologic Evidence of Burn at the Epigastric Port Site Skin. | 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. | 1 day | Yes |
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