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

Phase 4

• Conditions: Breast Cancer

• Registration Number: NCT01216254
• Lead Sponsor: Medical University of Gdansk

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-04
• Study First Submitted QC: 2010-10-06
• Study First Posted: 2010-10-07
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-30
• Last Update Posted: 2012-01-31
• Primary Completion: 2013-10
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Control	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

Name	Time	Method
Quality of life (QoL)	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	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	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.

Trial Locations

Locations (1)

Department of Surgical Oncology; 🇵🇱 Gdansk, Pomorskie, Poland