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Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery
Sponsor: Severance Hospital
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.
Official title: Prospective Cohort Study of Mastectomy With Reconstruction Including Robot Endoscopic Breast Surgery
Key Details
Gender
FEMALE
Age Range
19 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
2000
Start Date
2020-04-08
Completion Date
2030-04-07
Last Updated
2025-05-15
Healthy Volunteers
No
Conditions
Interventions
Robotic or endoscopic nipple sparing mastectomy
Cases or Patients who underwent robotic nipple-sparing mastectomy and immediate reconstruction are enrolled in this arm. Robotic nipple-sparing mastectomy should be performed using robotic surgical systems. Robotic surgical systems include da Vinci S,Si, X, Xi, and SP systems. Axillary or lateral incisions are used for this procedure. Immediate reconstruction includes tissue expander insertion, direct-to-implant, latissimus dorsi flap, transverse abdominis rectus muscle flap, or deep inferior epigastric perforators flap. Cases with robotic mastectomy without immediate reconstruction are excluded.
Conventional mastectomy (including nipple sparing mastectomy, skin sparing mastectomy)
Cases or Patients who underwent conventional mastectomy and immediate reconstruction are enrolled in this arm. Conventional mastectomy should not be performed using robotic or endoscopic surgical systems. Any incisions can be performed for this procedure. Conventional mastectomy includes also Nipple-sparing mastectomy and Skin sparing mastectomy. Immediate reconstruction includes tissue expander insertion, direct-to-implant, latissimus dorsi flap, transverse abdominis rectus muscle flap, or deep inferior epigastric perforators flap. Cases without immediate reconstruction are excluded.
Locations (18)
Kosin University Gospel Hospital
Busan, Busan, South Korea
Chungnam National University Sejong Hospital
Sejong, Chungcheongnam-do, South Korea
Kyungpook National University Chilgok Hospital
Daegu, Daegu, South Korea
Wonju Severance Christian hospital
Wŏnju, Gangwon-do, South Korea
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Myongji Hospital
Goyang-si, Gyeonggi-do, South Korea
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea
Samsung Changwon Medical Center
Changwon, Gyeongsangnam-do, South Korea
The Catholic University of Korea, Incheon ST. Mary's Hospital
Incheon, Incheon, South Korea
Korea University Anam Hospital
Seoul, Seoul, South Korea
Seoul National University Hospital
Seoul, Seoul, South Korea
Soonchunhyang University Hospital
Seoul, Seoul, South Korea
Gangnam Severance Hospital
Seoul, Seoul, South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, Seoul, South Korea
Korea University Guro Hospital
Seoul, Seoul, South Korea
Yonsei University College of Medicine
Seoul, Seoul, South Korea
Samsung Medical Center
Seoul, Seoul, South Korea
Asan Medical Center
Seoul, Seoul, South Korea