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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: classic v high-frequency electrocoagulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Classic electrocoagulation<br>Arm of the study where the classic low-frequency electrocoagulation is used during the operation | Device: classic v high-frequency electrocoagulation<br>* 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.<br>* Other names: Ellmann;|
| Experimental: High Frequency electrocoagulation<br>Arm of the study where the tested high-frequency electrocoagulation is used during the operation | Device: classic v high-frequency electrocoagulation<br>* 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.<br>* Other names: Ellmann;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, stage 2, breast conserving therapy, sentinel lymph node dissection, high frequency electrocoagulation