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.
18 Years
N/A
Female
Breast Cancer
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Pain Control
Outcome 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.
Outcome Time Frame:
From the day before surgery up to 12 weeks (+/-2days) after surgery
Safety Issue:
No
Principal Investigator
Jacek Zielinski, M.D., Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical University of Gdansk
Authority:
Poland: Ethics Committee
Study ID:
NKEBN/219/2010
NCT ID:
NCT01216254
Start Date:
October 2010
Completion Date:
October 2013
Related Keywords:
- Breast Cancer
- breast cancer
- stage 2
- breast conserving therapy
- sentinel lymph node dissection
- high frequency electrocoagulation
- Breast Neoplasms
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