Trial Outcomes & Findings for Surgical Trial Comparing LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Stand (NCT NCT01549925)

Results Overview

To evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

at time of surgery, up to 10 minutes

Results posted on

2016-01-28

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Surgical Resection standard surgical resection using clamps and surgical ligatures Standard Surgical resection: standard surgical resection using clamps and surgical ligatures	LIGASURE Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Surgical Trial Comparing LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Stand

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Surgical Resection n=25 Participants standard surgical resection using clamps and surgical ligatures Standard Surgical resection: standard surgical resection using clamps and surgical ligatures	LIGASURE n=25 Participants Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon	Total n=50 Participants Total of all reporting groups
Age, Customized < 50 years	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
Age, Customized 50-70 years	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Age, Customized >70 years	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: at time of surgery, up to 10 minutes

To evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures

Outcome measures

Outcome measures
Measure	Standard Surgical Resection n=25 Participants standard surgical resection using clamps and surgical ligatures Standard Surgical resection: standard surgical resection using clamps and surgical ligatures	LIGASURE n=25 Participants Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon
Surgical Time	417 SECONDS Interval 378.0 to 455.0	338 SECONDS Interval 296.0 to 379.0

Adverse Events

Standard Surgical Resection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LIGASURE

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

Mark Wade

Huntsman Cancer Institute

Phone: 801-213-5746

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place