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Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode Causing Thermal Injury at Port Site Skin

This study has been completed.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01664806
First received: August 10, 2012
Last updated: March 18, 2013
Last verified: March 2013

August 10, 2012
March 18, 2013
November 2010
August 2011   (final data collection date for primary outcome measure)
Histologic Thermal Injury to 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 primary outcome is histologic evidence of burn at this port sites.
Histologic thermal injury to epigastric and umbilical port site skin [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
Shave biopsy of skin at the epigastric and umbilical port sites after elective lataroscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at these port sites.
Complete list of historical versions of study NCT01664806 on ClinicalTrials.gov Archive Site
Histologic Evidence of Burn at the 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 secondary outcome is histologic evidence of burn at this port site.
Histologic evidence of burn at the right medial abominal wall port site skin [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
Shave biopsy of skin at the right abodminal wall medial port site after elective lataroscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port sites.
Not Provided
Not Provided
 
Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode Causing Thermal Injury at Port Site Skin
Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode and Thermal Injury to Tissue Adjacent to Port Sites

Monopolar radiofrequency energy is used to perform the laparoscopic cholecystectomy operation. The appearance of burns are common following laparoscopic cholecystectomy; particularly at the port site of the active electrode. Willson et al found that 9 out of 19 skin biopsies from the skin adjacent to the port site of the monopolar instrument's active electrode were found to have thermal injury by histology. [Willson et al. Surg Endosc (1997) 11:653] Authors have speculated that using different generator modes may lead to less capacitive coupling; [Wu et al Am J Surg (2000) 179: 67] although no data exists to support these speculations.

The investigators hypothesize that capacitive coupling electrosurgical injuries from monopolar instruments are occurring during laparoscopic cholecystectomy operations. The investigators hypothesize that use of blend modes will reduce the incidence of capacitive coupling thermal injuries during laparoscopic operations in comparison to coag modes.

SPECIFIC AIM:

Compare incidence of skin burns caused by using coag versus blend monopolar instrument modes at the active electrode port site (epigastric port), and at the non-active electrode port sites (umbilical and right abdominal wall).

OUTCOME MEASURE:

Histologic evidence of thermal injury at the skin biopsy sites of the active electrode port, the camera port and the medial assistant port. Histology will be performed by a blinded pathologist.

POPULATION TO BE ENROLLED:

Subjects undergoing elective laparoscopic cholecystectomy will be recruited in the principle investigators pre-operative clinic. All subjects will be 18 years and older.

STUDY DESIGN AND METHODS:

Written informed consent will be obtained in all subjects prior to enrollment. Subjects will be randomized on the day of surgery to undergo the laparoscopic cholecystectomy operation with either the coag or blend modes of using standard monopolar electrosurgery instruments. The randomization process will occur by using a random number generator. A total of 40 subjects will be recruited; 20 subjects per group. Shave skin biopsies will be performed at the edge of the incisions of the active electrode port, the camera port and the medial assistant port on the right abdominal wall. The incisions and skin will be otherwise opened and closed in the routine clinical manor.

STATISTICAL ANALYSIS The incidence of skin burns created using coag or blend modes will be compared individually at all three port sites using chi-squared or Fisher's exact test where appropriate. Baseline demographic data (e.g., gender, age, body mass index, operation time, blood loss, indication for operation and histology) will be compared in the two groups.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
  • Intraoperative Complications
  • Thermal Injury
  • Electrocoagulation
Device: Covidien Triad monopolar generator
Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.
  • No Intervention: Coag mode 30 Watts Power
    Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.
  • Experimental: Covidien Triad monopolar generator
    Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform Elective laparoscopic cholecystectomy. which is the experimental arm of the study's mode.
    Intervention: Device: Covidien Triad monopolar generator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2012
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients undergoing urgent or emergent laparoscopic cholecystectomy operations
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01664806
09-0049
No
University of Colorado, Denver
University of Colorado, Denver
Covidien
Principal Investigator: Thomas Robinson, MD University of Colorado, Denver
University of Colorado, Denver
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP