Trial Outcomes & Findings for Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode Causing Thermal Injury at Port Site Skin (NCT NCT01664806)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

40 participants

Primary outcome timeframe

1 day

Results posted on

2013-03-25

Participant Flow

40 patients were recruited at the University of Colorado Hospital.

Two screened patients were excluded because they refused entry into the trial.

Participant milestones

Participant milestones
Measure	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.	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
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts n=20 Participants 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.	Coag Mode 30 Watts Power n=20 Participants 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	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age Continuous	47 years STANDARD_DEVIATION 18 • n=5 Participants	41 years STANDARD_DEVIATION 12 • n=7 Participants	44 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: A sample size of convenience for feasibility.

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.

Outcome measures

Outcome measures
Measure	Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts n=20 Participants 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.	Coag Mode 30 Watts Power n=20 Participants 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
Histologic Thermal Injury to Epigastric Port Site Skin	1 participants	7 participants

SECONDARY outcome

Timeframe: 1 day

Population: A sample size of convenience for feasibility.

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.

Outcome measures

Outcome measures
Measure	Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts n=20 Participants 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.	Coag Mode 30 Watts Power n=20 Participants 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
Histologic Evidence of Burn at the Umbilical Port Site Skin	3 participants	11 participants

Adverse Events

Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Coag Mode 30 Watts Power

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Thomas Robinson

University of Colorado School of Medicine

Phone: 303-724-2728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place