N/A
N=94
The Use of a High-frequency Ultrasonic Knife in Breast Cancer Surgery
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00996632 ↗Enrolled (actual)
94
Serious AEs
—
Results posted
Oct 2009
Primary outcome: Primary: Drainage Volume — 182.6; 525.2 milliliters — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ultrasonic knife (Ultracision®, Ethicon Endo Surgery) (Procedure); conventional diarthermy knife (Procedure)
- Age
- Adult, Older Adult · 36+ yrs
- Sex
- All
- Sponsor
- University of Trieste
- Primary completion
- Sep 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drainage Volume |
182.6; 525.2 | <0.05 sig |
| SECONDARY Time of Discharge |
4.5; 8.1 | 0.05 |
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.
Eligibility Criteria
Inclusion Criteria
- Operable breast cancer
Exclusion Criteria
- Inoperable breast cancer
- BMI > 25
- Neoadiuvant radioterapy
- Carcinomastitis
- Previous phlebitis of omolateral arm
- Collagen disease
Data sourced from ClinicalTrials.gov (NCT00996632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.