NCT04585074Active, not recruiting
Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery
Prospective Cohort Study of Mastectomy With Reconstruction Including Robot Endoscopic Breast Surgery
Source: ClinicalTrials.gov · Last updated 15 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 18 Sept 2020
- Start date
- 8 Apr 2020
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Severance Hospital
- NCT number
- NCT04585074
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 8 Apr 2020 to the primary completion date, 30 Jun 2025
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who planned for surgery on both sides in the different methods
Other
- Patients scheduled for breast conserving mastectomy
- Patients who do not want immediate reconstruction during mastectomy
Who the study is looking for
- 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
Age in the registry: 19 years to 80 years · Sex: Female · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Korea University Ansan Hospital Coordinator of this site? Confirm its status | Ansan | South Korea | Unknown status |
| Kosin University Gospel Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Samsung Changwon Medical Center Coordinator of this site? Confirm its status | Changwon | South Korea | Unknown status |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| MyongJi Hospital Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| The Catholic University of Korea, Incheon St. Mary's Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Chungnam National University Sejong Hospital Coordinator of this site? Confirm its status | Sejong | South Korea | Unknown status |
| Seoul Metropolitan Government Seoul National University Boramae Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Gangnam Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Yonsei University College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Soonchunhyang University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Wonju Severance Christian Hospital Coordinator of this site? Confirm its status | Wŏnju | South Korea | Unknown status |
| Yongin Severance Hospital Coordinator of this site? Confirm its status | Yongin-si | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.