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Clinical Trials in South Korea / NCT04585074
Active, not recruiting Observational

Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery

NCT04585074 · tracked via the Priya Life Science South Korea tracker
Sponsor
Severance Hospital
Phase
Observational
Started
2020-04-08
Last updated
2025-05-15

Condition(s) studied

Breast NeoplasmsGermline BRCA1 Gene MutationGermline BRCA2 Gene MutationBenign Breast DiseaseGermline Mutation Abnormality

Investigational drug(s) / intervention(s)

Robotic or endoscopic nipple sparing mastectomyConventional mastectomy (including nipple sparing mastectomy, skin sparing mastectomy)

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
19 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Patients scheduled for breast conserving mastectomy * Patients who do not want immediate reconstruction during mastectomy * Patients who planned for surgery on both sides in the different methods

Primary outcome measure(s)

  • Postoperative complication rates in 30 days — Postoperative 30 days
    Postoperative complication rates are calculated as total number of postoperative complication cases per total operation cases.
  • Clavien-Dindo grade of postoperative complications — Postoperative 180 days
    Clavien-Dindo grade of postoperative complications is evaluated. The highest grade of postoperative complications are used for the analysis.

Trial sites (18)

FacilityCityRegionStatus
Kosin University Gospel Hospital Busan Busan
Chungnam National University Sejong Hospital Sejong Chungcheongnam-do
Kyungpook National University Chilgok Hospital Daegu Daegu
Wonju Severance Christian hospital Wŏnju Gangwon-do
Korea University Ansan Hospital Ansan Gyeonggi-do
Myongji Hospital Goyang-si Gyeonggi-do
Yongin Severance Hospital Yongin-si Gyeonggi-do
Samsung Changwon Medical Center Changwon Gyeongsangnam-do
The Catholic University of Korea, Incheon ST. Mary's Hospital Incheon Incheon
Korea University Anam Hospital Seoul Seoul
Seoul National University Hospital Seoul Seoul
Soonchunhyang University Hospital Seoul Seoul
Gangnam Severance Hospital Seoul Seoul
Seoul Metropolitan Government Seoul National University Boramae Medical Center Seoul Seoul
Korea University Guro Hospital Seoul Seoul
Yonsei University College of Medicine Seoul Seoul
Samsung Medical Center Seoul Seoul
Asan Medical Center Seoul Seoul

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04585074 on ClinicalTrials.gov ↗ ← All trials in South Korea