Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery
MARRES
Prospective Cohort Study of Mastectomy With Reconstruction Including Robot Endoscopic Breast Surgery
1 other identifier
observational
2,000
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 8, 2020
CompletedFirst Submitted
Initial submission to the registry
September 18, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 7, 2030
ExpectedMay 15, 2025
May 1, 2025
5.2 years
September 18, 2020
May 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Postoperative complication rates in 30 days
Postoperative complication rates are calculated as total number of postoperative complication cases per total operation cases.
Postoperative 30 days
Clavien-Dindo grade of postoperative complications
Clavien-Dindo grade of postoperative complications is evaluated. The highest grade of postoperative complications are used for the analysis.
Postoperative 180 days
Secondary Outcomes (6)
Recurrence free survival (RFS)
Postoperative 5 years
Cancer incidence rate
Postoperative 5 years
Patient's satisfaction (about reconstruction expectations)
within preoperative 4 weeks to operation and within postoperative 6 month to 12 month.(Patients who have undergone skin sparing mastectomy can do within up to 3 years)
Patient's satisfaction (about reconstruction results)
within preoperative 4 weeks to operation and within postoperative 6 month to 12 month.(Patients who have undergone skin sparing mastectomy can do within up to 3 years)
Surgeon's satisfaction
Postoperative 6 month to 12 month(Patients who have undergone skin sparing mastectomy can do within up to 3 years
- +1 more secondary outcomes
Interventions
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.
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.
Eligibility Criteria
Patients who underwent nipple-sparing mastectomy between 2020 and 2024 at Severance Hospital, Seoul, Korea
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Kosin University Gospel Hospital
Busan, Busan, 49267, South Korea
Chungnam National University Sejong Hospital
Sejong, Chungcheongnam-do, 30099, South Korea
Kyungpook National University Chilgok Hospital
Daegu, Daegu, 41404, South Korea
Wonju Severance Christian hospital
Wŏnju, Gangwon-do, 26426, South Korea
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 15355, South Korea
Myongji Hospital
Goyang-si, Gyeonggi-do, 10475, South Korea
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, 16995, South Korea
Samsung Changwon Medical Center
Changwon, Gyeongsangnam-do, 51353, South Korea
The Catholic University of Korea, Incheon ST. Mary's Hospital
Incheon, Incheon, 21431, South Korea
Korea University Anam Hospital
Seoul, Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, Seoul, 03080, South Korea
Soonchunhyang University Hospital
Seoul, Seoul, 04401, South Korea
Gangnam Severance Hospital
Seoul, Seoul, 06273, South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, Seoul, 07061, South Korea
Korea University Guro Hospital
Seoul, Seoul, 08308, South Korea
Yonsei University College of Medicine
Seoul, Seoul, 120-752, South Korea
Samsung Medical Center
Seoul, Seoul, 135-710, South Korea
Asan Medical Center
Seoul, Seoul, 138-736, South Korea
Related Publications (2)
Banfield S. A management systems analysis. Caring. 1987 Jul;6(7):45-50. No abstract available.
PMID: 10283322BACKGROUNDRyu JM, Lee J, Lee J, Ko B, Kim JH, Shin H, Park HS; Korea Robot-endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG). Mastectomy with Reconstruction Including Robotic Endoscopic Surgery (MARRES): a prospective cohort study of the Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG) and Korean Breast Cancer Study Group (KBCSG). BMC Cancer. 2023 Jun 21;23(1):571. doi: 10.1186/s12885-023-10978-0.
PMID: 37344780DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyung Seok Park, MD, PhD
Severance Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 18, 2020
First Posted
October 14, 2020
Study Start
April 8, 2020
Primary Completion
June 30, 2025
Study Completion (Estimated)
April 7, 2030
Last Updated
May 15, 2025
Record last verified: 2025-05