Clinical Trial Comparing Outcomes of Breast Conserving Operations With Classic v High-frequency Electrocoagulation
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
classic v high-frequency electrocoagulation
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, stage 2, breast conserving therapy, sentinel lymph node dissection, high frequency electrocoagulation
Eligibility 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
Sites / Locations
- Department of Surgical OncologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Classic electrocoagulation
High Frequency electrocoagulation
Arm Description
Arm of the study where the classic low-frequency electrocoagulation is used during the operation
Arm of the study where the tested high-frequency electrocoagulation is used during the operation
Outcomes
Primary Outcome Measures
Pain Control
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)
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
Number of days of lymphatic secretion would be assessed.
Amount of lymphatic secretion
Amount of lymphatic secretion would be measured until it stops on daily basis.
Full Information
NCT ID
NCT01216254
First Posted
October 4, 2010
Last Updated
January 30, 2012
Sponsor
Medical University of Gdansk
1. Study Identification
Unique Protocol Identification Number
NCT01216254
Brief Title
Clinical Trial Comparing Outcomes of Breast Conserving Operations With Classic v High-frequency Electrocoagulation
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Gdansk
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, stage 2, breast conserving therapy, sentinel lymph node dissection, high frequency electrocoagulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Classic electrocoagulation
Arm Type
Active Comparator
Arm Description
Arm of the study where the classic low-frequency electrocoagulation is used during the operation
Arm Title
High Frequency electrocoagulation
Arm Type
Experimental
Arm Description
Arm of the study where the tested high-frequency electrocoagulation is used during the operation
Intervention Type
Device
Intervention Name(s)
classic v high-frequency electrocoagulation
Other Intervention Name(s)
Ellmann
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Control
Description
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.
Time Frame
From the day before surgery up to 12 weeks (+/-2days) after surgery
Secondary Outcome Measure Information:
Title
Quality of life (QoL)
Description
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
Time Frame
From the day before surgery up to 12 weeks (+/-2days) after surgery
Title
Length of lymphatic secretion
Description
Number of days of lymphatic secretion would be assessed.
Time Frame
From the day before surgery up to 12 weeks (+/-2days) after surgery
Title
Amount of lymphatic secretion
Description
Amount of lymphatic secretion would be measured until it stops on daily basis.
Time Frame
From the day before surgery up to 12 weeks (+/-2days) after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacek Zielinski, M.D., Ph.D.
Phone
+48583492440
Email
jaziel@gumed.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Maciej Bobowicz, M.D.
Phone
+48608738614
Email
mbobowicz@gumed.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacek Zielinski, M.D., Ph.D.
Organizational Affiliation
Medical University of Gdansk
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janusz Jaskiewicz, M.D., Ph.D.
Organizational Affiliation
Medical University of Gdansk
Official's Role
Study Director
Facility Information:
Facility Name
Department of Surgical Oncology
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-211
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacek Zielinski, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Maciej Bobowicz, M.D.
First Name & Middle Initial & Last Name & Degree
Iwona Chruscicka, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Piotr Rak, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Pawel Kabata, M.D.
First Name & Middle Initial & Last Name & Degree
Radoslaw Jaworski, M.D., Ph.D.
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial Comparing Outcomes of Breast Conserving Operations With Classic v High-frequency Electrocoagulation
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