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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Classic electrocoagulation | Active Comparator | Arm of the study where the classic low-frequency electrocoagulation is used during the operation |
|
| High Frequency electrocoagulation | Experimental | Arm of the study where the tested high-frequency electrocoagulation is used during the operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| classic v high-frequency electrocoagulation | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacek Zielinski, M.D., Ph.D. | Contact | +48583492440 | jaziel@gumed.edu.pl | |
| Maciej Bobowicz, M.D. | Contact | +48608738614 | mbobowicz@gumed.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Jacek Zielinski, M.D., Ph.D. | Medical University of Gdansk | Principal Investigator |
| Janusz Jaskiewicz, M.D., Ph.D. | Medical University of Gdansk | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgical Oncology | Recruiting | Gdansk | Pomeranian Voivodeship | 80-211 | Poland |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |