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

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.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01216254

Enrollment

150

Registered

2010-10-07

Start date

2010-10-31

Completion date

2013-10-31

Last updated

2012-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, stage 2, breast conserving therapy, sentinel lymph node dissection, high frequency electrocoagulation

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.

Interventions

DEVICEclassic 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Poland

Contacts

Primary ContactJacek Zielinski, M.D., Ph.D.

jaziel@gumed.edu.pl+48583492440

Backup ContactMaciej Bobowicz, M.D.

mbobowicz@gumed.edu.pl+48608738614

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026