Fact CheckerSign in

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

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Korea University Ansan Hospital
Coordinator of this site? Confirm its status
AnsanSouth KoreaUnknown status
Kosin University Gospel Hospital
Coordinator of this site? Confirm its status
BusanSouth KoreaUnknown status
Samsung Changwon Medical Center
Coordinator of this site? Confirm its status
ChangwonSouth KoreaUnknown status
Kyungpook National University Chilgok Hospital
Coordinator of this site? Confirm its status
DaeguSouth KoreaUnknown status
MyongJi Hospital
Coordinator of this site? Confirm its status
Goyang-siSouth KoreaUnknown status
The Catholic University of Korea, Incheon St. Mary's Hospital
Coordinator of this site? Confirm its status
IncheonSouth KoreaUnknown status
Chungnam National University Sejong Hospital
Coordinator of this site? Confirm its status
SejongSouth KoreaUnknown status
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Korea University Guro Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Gangnam Severance Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Yonsei University College of Medicine
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Soonchunhyang University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Korea University Anam Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Wonju Severance Christian Hospital
Coordinator of this site? Confirm its status
WŏnjuSouth KoreaUnknown status
Yongin Severance Hospital
Coordinator of this site? Confirm its status
Yongin-siSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.