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

NCT ID: NCT01216254

Last Updated: 2012-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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breast cancer stage 2 breast conserving therapy sentinel lymph node dissection high frequency electrocoagulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Classic electrocoagulation

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

Group Type ACTIVE_COMPARATOR

classic v high-frequency electrocoagulation

Intervention Type DEVICE

During the BCT with SLND the investigators would use two types of electrocoagulation. The steps of the operation would remain the same in both arms, nevertheless the tool used would vary.

High Frequency electrocoagulation

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

Group Type EXPERIMENTAL

classic v high-frequency electrocoagulation

Intervention Type DEVICE

During the BCT with SLND the investigators would use two types of electrocoagulation. The steps of the operation would remain the same in both arms, nevertheless the tool used would vary.

Interventions

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classic v high-frequency electrocoagulation

During the BCT with SLND the investigators would use two types of electrocoagulation. The steps of the operation would remain the same in both arms, nevertheless the tool used would vary.

Intervention Type DEVICE

Other Intervention Names

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Ellmann

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Jacek Zielinski

Assistant Profesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacek Zielinski, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Gdansk

Janusz Jaskiewicz, M.D., Ph.D.

Role: STUDY_DIRECTOR

Medical University of Gdansk

Locations

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Department of Surgical Oncology

Gdansk, Pomeranian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Jacek Zielinski, M.D., Ph.D.

Role: CONTACT

Phone: +48583492440

Email: [email protected]

Maciej Bobowicz, M.D.

Role: CONTACT

Phone: +48608738614

Email: [email protected]

Other Identifiers

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NKEBN/219/2010

Identifier Type: -

Identifier Source: org_study_id