Electrocoagulation, Intraoperative Complications, Thermal Injury
Conditions
Keywords
Electrosurgery, Radiofrequency energy, Monopolar instruments, Capacitive coupling, Thermal injury, Surgical complications
Brief summary
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.
Detailed description
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.
Interventions
DEVICECovidien Triad monopolar generator
Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.
Sponsors
Medtronic - MITG
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years and older planned to undergo elective laparoscopic cholecystectomy
Exclusion criteria
* Patients undergoing urgent or emergent laparoscopic cholecystectomy operations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histologic Thermal Injury to Epigastric Port Site Skin | 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
| Measure | Time frame | Description |
|---|---|---|
| Histologic Evidence of Burn at the Umbilical Port Site Skin | 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. |
Countries
United States
Participant flow
Recruitment details
40 patients were recruited at the University of Colorado Hospital.
Pre-assignment details
Two screened patients were excluded because they refused entry into the trial.
Participants by arm
| Arm | Count |
|---|---|
| Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.
Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy. | 20 |
| Coag Mode 30 Watts Power Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.
Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Coag Mode 30 Watts Power | Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 18 Participants | 37 Participants |
| Age Continuous | 41 years STANDARD_DEVIATION 12 | 47 years STANDARD_DEVIATION 18 | 44 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Histologic Thermal Injury to Epigastric Port Site Skin
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.
Time frame: 1 day
Population: A sample size of convenience for feasibility.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts | Histologic Thermal Injury to Epigastric Port Site Skin | 1 participants |
| Coag Mode 30 Watts Power | Histologic Thermal Injury to Epigastric Port Site Skin | 7 participants |
Secondary
Histologic Evidence of Burn at the Umbilical Port Site Skin
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.
Time frame: 1 day
Population: A sample size of convenience for feasibility.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts | Histologic Evidence of Burn at the Umbilical Port Site Skin | 3 participants |
| Coag Mode 30 Watts Power | Histologic Evidence of Burn at the Umbilical Port Site Skin | 11 participants |