Clinical Trial Comparing Outcomes of Breast Conserving Operations With Classic v High-frequency Electrocoagulation
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
breast cancer, stage 2, breast conserving therapy, sentinel lymph node dissection, high frequency electrocoagulation
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: classic v high-frequency electrocoagulation
Type: Device
Overall Status
Recruiting
Summary
The aim of this study is to assess the outcomes of breast conserving therapy operation depending on the type of surgical tool used: classic electrocoagulation with higher operative temperatures and high frequency electrocoagulation with lower operative temperatures. The investigators would assess the pain levels, length and amount of the lymphatic secretion as well as quality of life following breast conserving surgery.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- female

- age 18-100

- breast cancer

- stage IIA and II B (cT1a-3; cN0-1; cM0)

- no previous breast surgery

- no previous cancer

- obtained informed consent

Exclusion Criteria:

- stages I, III, IV

- localised breast infection

- previous breast surgery for any cause

- previous cancer

- no voluntary consent
Location
Department of Surgical Oncology
Gdansk, Pomorskie, Poland
Status: Recruiting
Start Date
October 2010
Completion Date
October 2013
Sponsors
Medical University of Gdansk
Source
Medical University of Gdansk
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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