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

This study is currently recruiting participants.
Verified January 2012 by Medical University of Gdansk
Sponsor:
Information provided by (Responsible Party):
Jacek Zielinski, Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT01216254
First received: October 4, 2010
Last updated: January 30, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:

U.S. FDA Resources

Further study details as provided by Medical University of Gdansk:

Primary Outcome Measures:
  • Pain Control [ Time Frame: From the day before surgery up to 12 weeks (+/-2days) after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jacek Zielinski, Assistant Profesor, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT01216254     History of Changes
Other Study ID Numbers: NKEBN/219/2010
Study First Received: October 4, 2010
Last Updated: January 30, 2012
Health Authority: Poland: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on June 17, 2013