CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 94 enrolled
Drug / intervention
ultrasonic knife (Ultracision®, Ethicon Endo Surgery) +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00996632
NCT00996632N/ACompleted

Randomized Controlled Study of Benefits of Ultrasonic Knife in Breast Cancer Surgery

University of Trieste·interventional·Posted Oct 16, 2009·Updated Nov 11, 2009

In Brief

A clinical study evaluating ultrasonic knife (Ultracision®, Ethicon Endo Surgery) and conventional diarthermy knife for Breast Cancer. Completed, enrolled 94 participants across 2 sites.

Detailed Summary

Background: Lymphatic stasis and seroma formation are common complications of axillary lymphadenectomy in breast cancer surgery. The investigators aim is to test the hypothesis that the use of an ultrasonic knife for axillary dissection reduces the total amount and duration of persistent drainage and length of hospital stay. Method: The investigators have conducted a randomized trial on 94 patients (1 male, 93 females, mean age 64.7 years) who presented to the investigators unit with operable breast carcinoma. Patients in group A (38 cases) were operated on using exclusively the ultrasonic knife. Patients in group B (56 cases) were operated on using the conventional diathermy knife.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 16, 2009
Enrollment StartSep 1, 2000
Primary CompletionSep 1, 2004
Study CompletionNov 1, 2004
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 16.7 years ago

Interventions

ultrasonic knife (Ultracision®, Ethicon Endo Surgery)procedure

mastectomy or quadrantectomy and axillary dissection by an ultrasonic knife (Ultracision®, Ethicon Endo Surgery)

conventional diarthermy knifeprocedure

mastectomy or quadrantectomy and axillary dissection using conventional diarthermy knife