Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Breast Disease | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Germline BRCA1 Gene Mutation | — | UNRESOLVED | — |
| Germline BRCA2 Gene Mutation | — | UNRESOLVED | — |
| Germline Mutation Abnormality | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional mastectomy (including nipple sparing mastectomy, skin sparing mastectomy) | Procedure | — | UNRESOLVED |
| Robotic or endoscopic nipple sparing mastectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Postoperative complication rates in 30 days
- timeFrame
- Postoperative 30 days
- description
- Postoperative complication rates are calculated as total number of postoperative complication cases per total operation cases.
- measure
- Clavien-Dindo grade of postoperative complications
- timeFrame
- Postoperative 180 days
- description
- Clavien-Dindo grade of postoperative complications is evaluated. The highest grade of postoperative complications are used for the analysis.
Secondary outcomes (6)
- measure
- Recurrence free survival (RFS)
- timeFrame
- Postoperative 5 years
- description
- Events of RFS includes locoregional recurrence, distant recurrence, and death. Contralateral breast cancer and second primary malignancy are considered to be censored data.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDRyu 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 37344780