NCT01664806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 1, 2013

Completed
Last Updated

March 25, 2013

Status Verified

March 1, 2013

Enrollment Period

9 months

First QC Date

August 10, 2012

Results QC Date

January 25, 2013

Last Update Submit

March 18, 2013

Conditions

Intraoperative ComplicationsThermal InjuryElectrocoagulation

Keywords

ElectrosurgeryRadiofrequency energyMonopolar instrumentsCapacitive couplingThermal injurySurgical complications

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (1)

  • Histologic Evidence of Burn at the Umbilical Port Site Skin

    1 day

Study Arms (2)

Coag mode 30 Watts Power

NO INTERVENTION

Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.

Covidien Triad monopolar generator

EXPERIMENTAL

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

Interventions

Covidien Triad monopolar generatorDEVICE

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

Covidien Triad monopolar generator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • Jones EL, Dunn CL, Townsend NT, Jones TS, Bruce Dunne J, Montero PN, Govekar HR, Stiegmann GV, Robinson TN. Blend mode reduces unintended thermal injury by laparoscopic monopolar instruments: a randomized controlled trial. Surg Endosc. 2013 Nov;27(11):4016-20. doi: 10.1007/s00464-013-3032-2. Epub 2013 Jun 6.

    PMID: 23739984DERIVED

MeSH Terms

Conditions

Intraoperative ComplicationsHyperthermia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBody Temperature ChangesSigns and SymptomsHeat Stress DisordersWounds and Injuries

Limitations and Caveats

This is a pilot study with no funding so data is limited.

Results Point of Contact

Title
Dr. Thomas Robinson
Organization
University of Colorado School of Medicine
thomas.robinson@Ucdenver.edu
303-724-2728

Study Officials

  • Thomas Robinson, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2012

First Posted

August 14, 2012

Study Start

November 1, 2010

Primary Completion

August 1, 2011

Study Completion

May 1, 2012

Last Updated

March 25, 2013

Results First Posted

March 1, 2013

Record last verified: 2013-03

Locations

US(1)