Trial Outcomes & Findings for Bundling and Unbundling the Laparoscopic Electrosurgery Cord With the Camera Cord (NCT NCT01707095)

Results Overview

Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at these port sites.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

84 participants

Primary outcome timeframe

1 day

Results posted on

2014-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	Bundled Active electrode cord and camera cord parallel	Unbundled / Separated Active electrode cord and camera cord separated
Overall Study STARTED	42	42
Overall Study COMPLETED	42	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bundling and Unbundling the Laparoscopic Electrosurgery Cord With the Camera Cord

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bundling of Cords n=42 Participants The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy. Bundling of cords: The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.	Unbundling of Cords n=42 Participants The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another Unbundling of cords: The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another	Total n=84 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 15 • n=5 Participants	44 years STANDARD_DEVIATION 18 • n=7 Participants	44 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	32 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	42 participants n=7 Participants	84 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at these port sites.

Outcome measures

Outcome measures
Measure	Bundled n=42 Participants Active electrode cord and camera cord parallel	Unbundled / Separated n=42 Participants Active electrode cord and camera cord separated
Histologic Thermal Injury to Umbilical Port Site Skin	24 participants	13 participants

SECONDARY outcome

Timeframe: 1 day

Shave biopsy of skin at the epigastric 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	Bundled n=42 Participants Active electrode cord and camera cord parallel	Unbundled / Separated n=42 Participants Active electrode cord and camera cord separated
Histologic Evidence of Burn at the Epigastric Port Site Skin.	8 participants	11 participants

Adverse Events

Bundled

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unbundled / Separated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bundled n=42 participants at risk Active electrode cord and camera cord parallel	Unbundled / Separated n=42 participants at risk Active electrode cord and camera cord separated
Skin and subcutaneous tissue disorders	0.00% 0/42	0.00% 0/42

Other adverse events

Adverse event data not reported

Additional Information

Thomas Robinson

University of Colorado

Phone: 303-724-2728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place