Clinical Trial Comparing Outcomes of Breast Conserving Operations With Classic v High-frequency Electrocoagulation

Medical University of Gdansk

Status and phase: Unknown; Phase 4

Conditions: Breast Cancer

Treatments: Device: classic v high-frequency electrocoagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01216254

NKEBN/219/2010

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Classic electrocoagulation

Active Comparator group

Description:

Arm of the study where the classic low-frequency electrocoagulation is used during the operation

Treatment:

Device: classic v high-frequency electrocoagulation

High Frequency electrocoagulation

Experimental group

Description:

Arm of the study where the tested high-frequency electrocoagulation is used during the operation

Treatment:

Device: classic v high-frequency electrocoagulation