Under way, not recruiting

Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery

NCT04585074 · Severance Hospital · Updated 15 May 2025

What is being tested: Robotic or endoscopic nipple sparing mastectomy; Conventional mastectomy (including nipple sparing mastectomy, skin sparing mastectomy)
For: Breast Neoplasms; Germline BRCA1 Gene Mutation; Germline BRCA2 Gene Mutation; Benign Breast Disease; Germline Mutation Abnormality
Kind of study: Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join: Ages 19 years to 80 years. About 2,000 people. The full rules are on the registry page.
Where: South Korea (18 sites)
When: Starts or started 8 April 2020, ends 7 April 2030. Registered 14 Oct 2020.
Results: None posted yet.

In the researchers' words

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.

ClinicalTrials.gov, NCT04585074

Sites

Kosin University Gospel HospitalBusan, Busan, South Korea
Chungnam National University Sejong HospitalSejong, Chungcheongnam-do, South Korea
Kyungpook National University Chilgok HospitalDaegu, Daegu, South Korea
Wonju Severance Christian hospitalWŏnju, Gangwon-do, South Korea
Korea University Ansan HospitalAnsan, Gyeonggi-do, South Korea
Myongji HospitalGoyang-si, Gyeonggi-do, South Korea
Yongin Severance HospitalYongin-si, Gyeonggi-do, South Korea
Samsung Changwon Medical CenterChangwon, Gyeongsangnam-do, South Korea
The Catholic University of Korea, Incheon ST. Mary's HospitalIncheon, Incheon, South Korea
Korea University Anam HospitalSeoul, Seoul, South Korea
Seoul National University HospitalSeoul, Seoul, South Korea
Soonchunhyang University HospitalSeoul, Seoul, South Korea
Gangnam Severance HospitalSeoul, Seoul, South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical CenterSeoul, Seoul, South Korea
Korea University Guro HospitalSeoul, Seoul, South Korea
Yonsei University College of MedicineSeoul, Seoul, South Korea
Samsung Medical CenterSeoul, Seoul, South Korea
Asan Medical CenterSeoul, Seoul, South Korea