Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery

Active, not recruitingOBSERVATIONAL
Enrollment

2,000

Participants

Timeline

Start Date

April 8, 2020

Primary Completion Date

June 30, 2025

Study Completion Date

April 7, 2030

Conditions
Breast NeoplasmsGermline BRCA1 Gene MutationGermline BRCA2 Gene MutationBenign Breast DiseaseGermline Mutation Abnormality
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (18)

10475

Myongji Hospital, Goyang-si

15355

Korea University Ansan Hospital, Ansan

16995

Yongin Severance Hospital, Yongin-si

21431

The Catholic University of Korea, Incheon ST. Mary's Hospital, Incheon

26426

Wonju Severance Christian hospital, Wŏnju

30099

Chungnam National University Sejong Hospital, Sejong

41404

Kyungpook National University Chilgok Hospital, Daegu

49267

Kosin University Gospel Hospital, Busan

51353

Samsung Changwon Medical Center, Changwon

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

04401

Soonchunhyang University Hospital, Seoul

06273

Gangnam Severance Hospital, Seoul

07061

Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul

08308

Korea University Guro Hospital, Seoul

120-752

Yonsei University College of Medicine, Seoul

135-710

Samsung Medical Center, Seoul

138-736

Asan Medical Center, Seoul

All Listed Sponsors
lead

Severance Hospital

OTHER