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

NCT00996632 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2009-11-11

Study results available
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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.

Conditions

Interventions

PROCEDURE

ultrasonic knife (Ultracision®, Ethicon Endo Surgery)

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

PROCEDURE

conventional diarthermy knife

mastectomy or quadrantectomy and axillary dissection using conventional diarthermy knife

Sponsors & Collaborators

  • University of Trieste

    lead OTHER

Principal Investigators

  • Nicolò de Manzini, Professor · University of Trieste

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
36 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-09-30
Primary Completion
2004-09-30
Completion
2004-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00996632 on ClinicalTrials.gov