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

NCT01664806 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-03-25

Study results available
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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.

Conditions

  • Intraoperative Complications
  • Thermal Injury
  • Electrocoagulation

Interventions

DEVICE

Covidien Triad monopolar generator

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

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Thomas Robinson, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-08-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01664806 on ClinicalTrials.gov