Bundling and Unbundling the Laparoscopic Electrosurgery Cord With the Camera Cord

NCT01707095 | Completed Results

• 1 other identifier: 12-0906
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fatigue

Keywords

Electrosurgery; Radiofrequency energy; Monopolar instruments; Capacitive coupling; Thermal injury; Surgical complications

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Histologic Evidence of Burn at the Epigastric Port Site Skin.

  1 day

Study Arms (2)

Bundling of cords

EXPERIMENTAL

The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.

Other: Bundling of cords

Unbundling of cords

EXPERIMENTAL

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

Interventions

Unbundling of cords OTHER

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

Unbundling of cords

Bundling of cords OTHER

The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.

Bundling of cords

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients undergoing urgent or emergent laparoscopic cholecystectomy operations
• Patients younger than 18

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (4)

• 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. doi: 10.1007/s004649900414.

  PMID: 9171127 BACKGROUND

• 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. doi: 10.1016/s0002-9610(99)00267-6.

  PMID: 10737583 BACKGROUND

• 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.

  PMID: 22580879 BACKGROUND

• Robinson TN, Jones EL, Dunn CL, Dunne B, Johnson E, Townsend NT, Paniccia A, Stiegmann GV. Separating the Laparoscopic Camera Cord From the Monopolar "Bovie" Cord Reduces Unintended Thermal Injury From Antenna Coupling: A Randomized Controlled Trial. Ann Surg. 2015 Jun;261(6):1056-60. doi: 10.1097/SLA.0000000000000841.

  PMID: 26291952 DERIVED

MeSH Terms

Conditions

Fatigue; Hyperthermia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Heat Stress Disorders; Wounds and Injuries

Results Point of Contact

• Title: Thomas Robinson
• Organization: University of Colorado

thomas.robinson@ucdenver.edu

303-724-2728

Study Officials

• Thomas N Robinson, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: October 15, 2012
• Study Start: September 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: July 17, 2014
• Results First Posted: June 27, 2014

Record last verified: 2014-07

Locations

US (1)