Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery (NCT04585074) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery
South Korea2,000 participantsStarted 2020-04-08
Plain-language summary
Robotic mastectomy and immediate reconstruction have been introduced in 2015. However, since robotic mastectomy is the latest surgical technique, there is a lack of studies prospectively comparing conventional mastectomy and immediate reconstruction with robotic mastectomy. For this reason, this study is designed to establish a single institution cohort study that prospectively collects patients undergoing mastectomy and reconstruction. This study was initially designed as a single institution study, however, currently, the study was extended to the multicenter study including 18 institutions over the country. Using the established prospective cohort data, a comparative study of robotic mastectomy with conventional mastectomy and reconstruction, and cost-effectiveness and satisfaction of robotic endoscopic surgery, and cost-effectiveness and satisfaction of reconstructive surgery are to be analyzed.
Who can participate
Age range
19 Years – 80 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:
* Female patient between the ages of 19 and 80
* Patients with breast cancer or high risk of breast cancer ( BRCA1/2 mutation, TP53 mutation, PALB2, etc.)
* Patients scheduled for therapeutic or prophylactic mastectomy (including conventional mastectomy, skin sparing mastectomy, areolar conserving mastectomy)
* Patients who want immediate reconstruction during mastectomy
* Those agreed in writing consent to participate study
Exclusion Criteria:
* Patients scheduled for breast conserving mastectomy
* Patients who do not want immediate reconstruction during mastectomy
* Patients who planned for surgery on both sides in the different methods
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.
1This study is specifically looking at mastectomy with robotic or endoscopic reconstruction — how does this surgical approach differ from the standard open mastectomy I might otherwise have, and what does that mean for my recovery and scarring?
2Since this trial is no longer actively enrolling, is there a similar or follow-up study I could be considered for, or would my doctor recommend a standard surgical approach based on what's already been learned from this research?
3The study is tracking complications in the first 30 days after surgery using a grading system called Clavien-Dindo — based on results so far, what kinds of complications have been most commonly reported with this robotic technique, and how do they compare to traditional mastectomy complication rates?
4I have a BRCA mutation — would my doctor say this type of robotic-assisted mastectomy is an appropriate option for someone in my situation, or are there reasons a conventional approach might be safer or more suitable for me specifically?
5Since this is listed as 'phase not applicable,' meaning it's more of an observational or procedural study than a drug trial, what does that tell us about how much is already known about the safety and effectiveness of robotic mastectomy reconstruction, and should I be asking about longer-term outcomes beyond 30 days?
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
1
Postoperative complication rates in 30 days
Timeframe: Postoperative 30 days
2
Clavien-Dindo grade of postoperative complications