CompletedNot Applicable

ELectrosurgical Bipolar Devices VS Conventional Electro-cauterization in Breast Surgery

South Korea82 participantsStarted 2017-05-01

Plain-language summary

There was no study about application of electrosurgical bipolar sealing device for mastectomy in Korean population, because Korean national insurance did not cover use of the advanced sealing device until last year. Sample size of the previous studies was too small to draw a solid conclusion. Therefore, this study was designed prospectively to evaluate whether application of bipolar energy device for mastectomy could provide clinical benefit in terms of reducing seroma formation.

Who can participate

Age range

20 Years – 100 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 20 years old and over * Patients planned to undergo total mastectomy and axillary lymph node dissection * Patients planned to undergo total mastectomy and sentinel lymph node biopsy and/or reconstruction * Patients planned to undergo partial mastectomy and axillary lymph node dissection Exclusion Criteria: * Bilateral breast cancer patients * Male breast cancer patients * Patients who underwent ipsilateral axillar surgery or axillar radiation therapy * Recurrent breast cancer patients * Patients who cannot give informed consents such as non-Korean speakers and patients with intellectual disabilities * Vulnerable patients such as pregnant women for enrollment * Patients without drain catheter * Patients with Ductal carcinoma in situ who have not undergone ipsilateral sentinel lymph node biopsy or axillar lymph node dissection

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total drainage volume after surgery: mL

Timeframe: Up to 30 weeks after surgery

Trial details

NCT IDNCT03166384

SponsorSeverance Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-01

View on ClinicalTrials.gov More Seroma as Procedural Complication trials