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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Jacek Zielinski, Medical University of Gdansk.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01216254
First Posted: October 7, 2010
Last Update Posted: January 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jacek Zielinski, Medical University of Gdansk
  Purpose
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.

Condition Intervention Phase
Breast Cancer Device: classic v high-frequency electrocoagulation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Jacek Zielinski, Medical University of Gdansk:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

  • 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.

  • 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.


Estimated Enrollment: 150
Study Start Date: October 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Ellmann

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216254


Contacts
Contact: Jacek Zielinski, M.D., Ph.D. +48583492440 jaziel@gumed.edu.pl
Contact: Maciej Bobowicz, M.D. +48608738614 mbobowicz@gumed.edu.pl

Locations
Poland
Department of Surgical Oncology Recruiting
Gdansk, Pomorskie, Poland, 80-211
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.         
Sponsors and Collaborators
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
  More Information

Responsible Party: Jacek Zielinski, Assistant Profesor, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT01216254     History of Changes
Other Study ID Numbers: NKEBN/219/2010
First Submitted: October 4, 2010
First Posted: October 7, 2010
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by Jacek Zielinski, Medical University of Gdansk:
breast cancer
stage 2
breast conserving therapy
sentinel lymph node dissection
high frequency electrocoagulation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases


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