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

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01216254
• Other study ID #: NKEBN/219/2010
• Status: Recruiting
• Phase: Phase 4
• First received: October 4, 2010
• Last updated: January 30, 2012
• Start date: October 2010
• Est. completion date: October 2013

Study information

• Verified date: January 2012
• Source: Medical University of Gdansk
• Contact: Jacek Zielinski, M.D., Ph.D.
• Phone: +48583492440
• Email: jaziel[@]gumed.edu.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Poland	Department of Surgical Oncology	Gdansk	Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From the day before surgery up to 12 weeks (+/-2days) after surgery	No
Secondary	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	From the day before surgery up to 12 weeks (+/-2days) after surgery	No
Secondary	Length of lymphatic secretion	Number of days of lymphatic secretion would be assessed.	From the day before surgery up to 12 weeks (+/-2days) after surgery	No
Secondary	Amount of lymphatic secretion	Amount of lymphatic secretion would be measured until it stops on daily basis.	From the day before surgery up to 12 weeks (+/-2days) after surgery	No