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

March 18, 2013 updated by: University of Colorado, Denver

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients undergoing urgent or emergent laparoscopic cholecystectomy operations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Covidien Triad monopolar generator
Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Medtronic - MITG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

August 10, 2012

First Submitted That Met QC Criteria

August 13, 2012

First Posted (Estimate)

August 14, 2012

Study Record Updates

Last Update Posted (Estimate)

March 25, 2013

Last Update Submitted That Met QC Criteria

March 18, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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