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

January 30, 2012 updated by: Jacek Zielinski, Medical University of Gdansk

Prospective, Randomized Clinical Trial Comparing Pain Sensation, Seroma Formation and Quality od Life Following BCT With SLND in Breast Cancer Patients Operated With Classic Versus High-frequency Electrocoagulation.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-211
        • Recruiting
        • Department of Surgical Oncology
        • Principal Investigator:
          • Jacek Zielinski, M.D., Ph.D.
        • Sub-Investigator:
          • Maciej Bobowicz, M.D.
        • Sub-Investigator:
          • Iwona Chruscicka, M.D., Ph.D.
        • Sub-Investigator:
          • Piotr Rak, M.D., Ph.D.
        • Sub-Investigator:
          • Pawel Kabata, M.D.
        • Sub-Investigator:
          • Radoslaw Jaworski, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Classic electrocoagulation
Arm of the study where the classic low-frequency electrocoagulation is used during the operation
Device: 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.
Other Names:
  • Ellmann
Experimental: High Frequency electrocoagulation
Arm of the study where the tested high-frequency electrocoagulation is used during the operation
Device: 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.
Other Names:
  • Ellmann

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Control
Time Frame: From the day before surgery up to 12 weeks (+/-2days) after surgery
Pain assessment would be performed using Visual Analogue Scale (VAS) at the days 1-5, 10 (+/- 2), 20 (+/- 2), 30 (+/- 2), and 12 weeks (+/- 2 days). SF - MPQ questionnaire would be filled in on admission, 10th (+/- 2) post-operative day and 12 weeks (+/- 2 days)after surgery.
From the day before surgery up to 12 weeks (+/-2days) after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (QoL)
Time Frame: From the day before surgery up to 12 weeks (+/-2days) after surgery
Pre-operative assessment of QoL would be performed by psychologist using questionnaires: CISS, HADS - M, Eysencka. Postoperative assessment of QoL would be performed using QLQ C30 and QLQ BR 23 questionnaires 12 weeks (+/- 2 days)after surgery
From the day before surgery up to 12 weeks (+/-2days) after surgery
Length of lymphatic secretion
Time Frame: From the day before surgery up to 12 weeks (+/-2days) after surgery
Number of days of lymphatic secretion would be assessed.
From the day before surgery up to 12 weeks (+/-2days) after surgery
Amount of lymphatic secretion
Time Frame: From the day before surgery up to 12 weeks (+/-2days) after surgery
Amount of lymphatic secretion would be measured until it stops on daily basis.
From the day before surgery up to 12 weeks (+/-2days) after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Investigators

  • Principal Investigator: Jacek Zielinski, M.D., Ph.D., Medical University of Gdansk
  • Study Director: Janusz Jaskiewicz, M.D., Ph.D., Medical University of Gdansk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

October 4, 2010

First Submitted That Met QC Criteria

October 6, 2010

First Posted (Estimate)

October 7, 2010

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 30, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKEBN/219/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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