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Completed

NCT Number: NCT01664806

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

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.

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Key information

Conditions

Intraoperative Complications Body Temperature Changes Electrocoagulation Heat Stress Disorders Hyperthermia Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Thermal Injury Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients undergoing urgent or emergent laparoscopic cholecystectomy operations

Treatment and study plan

Covidien Triad monopolar generator

Device

Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.

Primary outcomes

  1. Histologic Thermal Injury to Epigastric Port Site Skin

    Time frame: 1 day

    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.

Secondary outcomes

  1. Histologic Evidence of Burn at the Umbilical Port Site Skin

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Medtronic - MITG

Registry information

Official study title

Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode and Thermal Injury to Tissue Adjacent to Port Sites

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Aug 14, 2012
Registry last updated
Mar 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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