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

Completed · Phase 3

Conditions studied: Intraoperative Complications, Thermal Injury, Electrocoagulation

In brief

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.

Key facts

Study ID

NCT01664806

Run by

University of Colorado, Denver

People needed

40

Starts

2010-11-01

Expected to finish

2012-05-01

Last updated by the study team

2013-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• Patients undergoing urgent or emergent laparoscopic cholecystectomy operations

Where it is running

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

Full record on ClinicalTrials.gov

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