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.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Medical University of Gdansk
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Pain Control
- Last Updated
- 14 years ago
Overview
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.
Investigators
Jacek Zielinski
Assistant Profesor
Medical University of Gdansk
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
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 Outcomes
- Quality of life (QoL)(From the day before surgery up to 12 weeks (+/-2days) after surgery)
- Length of lymphatic secretion(From the day before surgery up to 12 weeks (+/-2days) after surgery)
- Amount of lymphatic secretion(From the day before surgery up to 12 weeks (+/-2days) after surgery)