Trial Outcomes & Findings for The Use of a High-frequency Ultrasonic Knife in Breast Cancer Surgery (NCT NCT00996632)

NCT ID: NCT00996632

Last Updated: 2009-11-11

Results Overview

volume in milliliters of axillary drainage

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 94 participants
• Primary outcome timeframe: discharge day
• Results posted on: 2009-11-11

Participant Flow

Patients affected by Breast Cancer

Participant milestones

Measure	Ultrasonic Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)	Conventional Patients were operated by a conventional diatherm knife
Overall Study STARTED	38	56
Overall Study COMPLETED	38	56
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Ultrasonic Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)	Conventional Patients were operated by a conventional diatherm knife
Overall Study Physician Decision	0	0

Baseline Characteristics

The Use of a High-frequency Ultrasonic Knife in Breast Cancer Surgery

Baseline characteristics by cohort

Measure	Ultrasonic n=38 Participants Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)	Conventional n=56 Participants Patients were operated by a conventional diatherm knife	Total n=94 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	19 Participants n=5 Participants	26 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	30 Participants n=7 Participants	49 Participants n=5 Participants
Age Continuous	64.6 years STANDARD_DEVIATION 12.3 • n=5 Participants	65.0 years STANDARD_DEVIATION 12.5 • n=7 Participants	64.7 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	56 Participants n=7 Participants	93 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Italy	38 participants n=5 Participants	56 participants n=7 Participants	94 participants n=5 Participants

PRIMARY outcome

Timeframe: discharge day

Population: the number of participants for analysis was determined by mean of power sample size calculation

volume in milliliters of axillary drainage

Outcome measures

Measure	Ultrasonic n=38 Participants Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)	Conventional n=56 Participants Patients were operated by a conventional diatherm knife
Drainage Volume	182.6 milliliters Standard Deviation 267.1	525.2 milliliters Standard Deviation 629.0

SECONDARY outcome

Timeframe: days

evaluation about the time of discharge from hospital

Outcome measures

Measure	Ultrasonic n=38 Participants Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)	Conventional n=56 Participants Patients were operated by a conventional diatherm knife
Time of Discharge	4.5 Days Standard Deviation 2.1	8.1 Days Standard Deviation 5.1

Adverse Events

Ultrasonic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional

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

Prof. Nicolò de Manzini

University of Trieste

Phone: +390403994152

Email: nicolo.demanzini@aots.sanita.fvg.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60